{
  "dataset": {
    "name": "Aesthetic Device Clearances (FDA 510(k))",
    "url": "https://nphla.com/trackers/aesthetic-device-clearances",
    "description": "FDA 510(k) clearance decisions for energy-based and other aesthetic devices — microneedling, radiofrequency, intense pulsed light, hair removal, body contouring, skin resurfacing and cryolipolysis — with the applicant, product code and decision date.",
    "publisher": "National Pharmacy Health & Leadership Alliance",
    "howToCite": "National Pharmacy Health & Leadership Alliance (NPHLA). nphla.com. “Aesthetic Device Clearances (FDA 510(k)).” Updated Oct 1, 2026. https://nphla.com/trackers/aesthetic-device-clearances. Accessed October 1, 2026.",
    "kind": "Aesthetic device clearances (FDA 510(k))",
    "dataOrigin": "NPHLA analysis of public data",
    "jurisdiction": "United States (federal)",
    "methodology": "The Intelligence pipeline queries openFDA’s 510(k) endpoint for device names that include the aesthetic terms above, excluding dental, ophthalmic, surgical-smoke and ablation-catheter devices, on the schedule set in the Source Registry. Each clearance is stored with FDA’s decision, decision date, applicant and product code, and links to its record in FDA’s 510(k) database.",
    "coverage": "U.S. federal (FDA) 510(k) decisions matching the search terms since tracking began. Devices authorized through other pathways (De Novo, premarket approval) and devices described with other terms are not included.",
    "limitations": "A 510(k) clearance means FDA found a device substantially equivalent to a legally marketed device. Clearance is not approval and does not by itself establish effectiveness for every use promoted. Keyword searches can include or miss devices. Not medical advice.",
    "updateFrequency": "Checked about every 12 hours, as configured in the Source Registry.",
    "selection": "Official records (device clearance) from primary sources.",
    "systemCheckedAt": "2026-10-01T09:05:09.790Z",
    "editoriallyReviewedAt": null,
    "editorialReview": "pending",
    "generatedAt": "2026-10-01T19:37:48.927Z",
    "recordCount": 20,
    "notAdvice": "Professional information compiled from public sources. Not medical, legal or regulatory advice; always confirm in the primary source."
  },
  "columns": [
    {
      "key": "applicant",
      "label": "Applicant"
    },
    {
      "key": "productCode",
      "label": "Product code"
    }
  ],
  "records": [
    {
      "key": "item:57",
      "record": "Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)",
      "subtitle": "510(k) K262524",
      "detail": "Substantially Equivalent on 2026-09-18. Review panel: General, Plastic Surgery. Product code OHT.",
      "status": "Substantially Equivalent",
      "fields": {
        "recordType": "Device clearance",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "applicant": "ONE BEAUTY Technology Co., Ltd.",
        "productCode": "OHT",
        "kNumber": "K262524"
      },
      "jurisdiction": "US",
      "date": "2026-09-18T00:00:00.000Z",
      "dateType": "Decision date",
      "source": {
        "title": "FDA 510(k) clearance: Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) (ONE BEAUTY Technology Co., Ltd.)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262524",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:10.249Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:25.686Z",
      "change": {
        "note": "Clearance decision recorded",
        "at": "2026-09-18T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:58",
      "record": "Hair Removal Device (R3C16-G Pro, R3C16-V Pro)",
      "subtitle": "510(k) K261705",
      "detail": "Substantially Equivalent on 2026-08-10. Review panel: General, Plastic Surgery. Product code OHT.",
      "status": "Substantially Equivalent",
      "fields": {
        "recordType": "Device clearance",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "applicant": "Shenzhen Jianchao Intelligent Technology Co., Ltd.",
        "productCode": "OHT",
        "kNumber": "K261705"
      },
      "jurisdiction": "US",
      "date": "2026-08-10T00:00:00.000Z",
      "dateType": "Decision date",
      "source": {
        "title": "FDA 510(k) clearance: Hair Removal Device (R3C16-G Pro, R3C16-V Pro) (Shenzhen Jianchao Intelligent Technology Co., Ltd.)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261705",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:10.249Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:25.576Z",
      "change": {
        "note": "Clearance decision recorded",
        "at": "2026-08-10T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:59",
      "record": "Diode laser hair removal machine (QDTM-04)",
      "subtitle": "510(k) K261693",
      "detail": "Substantially Equivalent on 2026-07-17. Review panel: General, Plastic Surgery. Product code GEX.",
      "status": "Substantially Equivalent",
      "fields": {
        "recordType": "Device clearance",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "applicant": "Beijing Nubway S&T Co., Ltd.",
        "productCode": "GEX",
        "kNumber": "K261693"
      },
      "jurisdiction": "US",
      "date": "2026-07-17T00:00:00.000Z",
      "dateType": "Decision date",
      "source": {
        "title": "FDA 510(k) clearance: Diode laser hair removal machine (QDTM-04) (Beijing Nubway S&T Co., Ltd.)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261693",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:10.249Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:25.546Z",
      "change": {
        "note": "Clearance decision recorded",
        "at": "2026-07-17T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:60",
      "record": "Intense Pulsed Light Therapy Device",
      "subtitle": "510(k) K261204",
      "detail": "Substantially Equivalent on 2026-06-12. Review panel: General, Plastic Surgery. Product code ONF.",
      "status": "Substantially Equivalent",
      "fields": {
        "recordType": "Device clearance",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "applicant": "Sanhe LEFIS Electronics Co., Ltd.",
        "productCode": "ONF",
        "kNumber": "K261204"
      },
      "jurisdiction": "US",
      "date": "2026-06-12T00:00:00.000Z",
      "dateType": "Decision date",
      "source": {
        "title": "FDA 510(k) clearance: Intense Pulsed Light Therapy Device (Sanhe LEFIS Electronics Co., Ltd.)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261204",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:10.249Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:25.509Z",
      "change": {
        "note": "Clearance decision recorded",
        "at": "2026-06-12T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:61",
      "record": "Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)",
      "subtitle": "510(k) K261325",
      "detail": "Substantially Equivalent on 2026-05-21. Review panel: General, Plastic Surgery. Product code OHT.",
      "status": "Substantially Equivalent",
      "fields": {
        "recordType": "Device clearance",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
        "productCode": "OHT",
        "kNumber": "K261325"
      },
      "jurisdiction": "US",
      "date": "2026-05-21T00:00:00.000Z",
      "dateType": "Decision date",
      "source": {
        "title": "FDA 510(k) clearance: Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) (Shenzhen Ulike Smart Electronics Co., Ltd.)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261325",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:10.249Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:25.479Z",
      "change": {
        "note": "Clearance decision recorded",
        "at": "2026-05-21T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:62",
      "record": "IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)",
      "subtitle": "510(k) K260594",
      "detail": "Substantially Equivalent on 2026-05-20. Review panel: General, Plastic Surgery. Product code OHT.",
      "status": "Substantially Equivalent",
      "fields": {
        "recordType": "Device clearance",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "applicant": "Shenzhen Xiazhifeng Electronic Co., Ltd.",
        "productCode": "OHT",
        "kNumber": "K260594"
      },
      "jurisdiction": "US",
      "date": "2026-05-20T00:00:00.000Z",
      "dateType": "Decision date",
      "source": {
        "title": "FDA 510(k) clearance: IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM) (Shenzhen Xiazhifeng Electronic Co., Ltd.)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260594",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:10.249Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:25.438Z",
      "change": {
        "note": "Clearance decision recorded",
        "at": "2026-05-20T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:63",
      "record": "AYON Body Contouring System™  (AYON SYSTEM)",
      "subtitle": "510(k) K253396",
      "detail": "Substantially Equivalent on 2026-05-08. Review panel: General, Plastic Surgery. Product code QPB.",
      "status": "Substantially Equivalent",
      "fields": {
        "recordType": "Device clearance",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "applicant": "Apyx Medical Corporation",
        "productCode": "QPB",
        "kNumber": "K253396"
      },
      "jurisdiction": "US",
      "date": "2026-05-08T00:00:00.000Z",
      "dateType": "Decision date",
      "source": {
        "title": "FDA 510(k) clearance: AYON Body Contouring System™  (AYON SYSTEM) (Apyx Medical Corporation)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253396",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:10.249Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:25.401Z",
      "change": {
        "note": "Clearance decision recorded",
        "at": "2026-05-08T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:64",
      "record": "Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)",
      "subtitle": "510(k) K260742",
      "detail": "Substantially Equivalent on 2026-05-05. Review panel: General, Plastic Surgery. Product code OHT.",
      "status": "Substantially Equivalent",
      "fields": {
        "recordType": "Device clearance",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
        "productCode": "OHT",
        "kNumber": "K260742"
      },
      "jurisdiction": "US",
      "date": "2026-05-05T00:00:00.000Z",
      "dateType": "Decision date",
      "source": {
        "title": "FDA 510(k) clearance: Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK) (Shenzhen Ulike Smart Electronics Co., Ltd.)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260742",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:10.249Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:25.363Z",
      "change": {
        "note": "Clearance decision recorded",
        "at": "2026-05-05T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:65",
      "record": "IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)",
      "subtitle": "510(k) K260518",
      "detail": "Substantially Equivalent on 2026-04-21. Review panel: General, Plastic Surgery. Product code OHT.",
      "status": "Substantially Equivalent",
      "fields": {
        "recordType": "Device clearance",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "applicant": "Shenzhen Semlamp Intelligent Technology Co., Ltd.",
        "productCode": "OHT",
        "kNumber": "K260518"
      },
      "jurisdiction": "US",
      "date": "2026-04-21T00:00:00.000Z",
      "dateType": "Decision date",
      "source": {
        "title": "FDA 510(k) clearance: IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F) (Shenzhen Semlamp Intelligent Technology Co., Ltd.)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260518",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:10.249Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:25.331Z",
      "change": {
        "note": "Clearance decision recorded",
        "at": "2026-04-21T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:66",
      "record": "Disposable Radiofrequency Cannula",
      "subtitle": "510(k) K253907",
      "detail": "Substantially Equivalent on 2026-04-16. Review panel: Neurology. Product code GXI.",
      "status": "Substantially Equivalent",
      "fields": {
        "recordType": "Device clearance",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "applicant": "ABBOTT MEDICAL",
        "productCode": "GXI",
        "kNumber": "K253907"
      },
      "jurisdiction": "US",
      "date": "2026-04-16T00:00:00.000Z",
      "dateType": "Decision date",
      "source": {
        "title": "FDA 510(k) clearance: Disposable Radiofrequency Cannula (ABBOTT MEDICAL)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253907",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:10.249Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:25.298Z",
      "change": {
        "note": "Clearance decision recorded",
        "at": "2026-04-16T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:67",
      "record": "Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)",
      "subtitle": "510(k) K254047",
      "detail": "Substantially Equivalent on 2026-03-11. Review panel: General, Plastic Surgery. Product code OHT.",
      "status": "Substantially Equivalent",
      "fields": {
        "recordType": "Device clearance",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "applicant": "Shenzhen Chuangtong Yigou Technology Co., Ltd.",
        "productCode": "OHT",
        "kNumber": "K254047"
      },
      "jurisdiction": "US",
      "date": "2026-03-11T00:00:00.000Z",
      "dateType": "Decision date",
      "source": {
        "title": "FDA 510(k) clearance: Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025) (Shenzhen Chuangtong Yigou Technology Co., Ltd.)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254047",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:10.249Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:25.269Z",
      "change": {
        "note": "Clearance decision recorded",
        "at": "2026-03-11T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:68",
      "record": "IPL Hair Removal Device (Models: T31A, T32A)",
      "subtitle": "510(k) K253666",
      "detail": "Substantially Equivalent on 2026-02-23. Review panel: General, Plastic Surgery. Product code OHT.",
      "status": "Substantially Equivalent",
      "fields": {
        "recordType": "Device clearance",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "applicant": "Shenzhen Mlay Intelligent Technology Co., Ltd.",
        "productCode": "OHT",
        "kNumber": "K253666"
      },
      "jurisdiction": "US",
      "date": "2026-02-23T00:00:00.000Z",
      "dateType": "Decision date",
      "source": {
        "title": "FDA 510(k) clearance: IPL Hair Removal Device (Models: T31A, T32A) (Shenzhen Mlay Intelligent Technology Co., Ltd.)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253666",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:10.249Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:25.238Z",
      "change": {
        "note": "Clearance decision recorded",
        "at": "2026-02-23T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:69",
      "record": "808nm semiconductor laser hair removal machine",
      "subtitle": "510(k) K252048",
      "detail": "Substantially Equivalent on 2026-02-03. Review panel: General, Plastic Surgery. Product code GEX.",
      "status": "Substantially Equivalent",
      "fields": {
        "recordType": "Device clearance",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "applicant": "Xi'An Taibo Electronic Technology Co., Ltd.",
        "productCode": "GEX",
        "kNumber": "K252048"
      },
      "jurisdiction": "US",
      "date": "2026-02-03T00:00:00.000Z",
      "dateType": "Decision date",
      "source": {
        "title": "FDA 510(k) clearance: 808nm semiconductor laser hair removal machine (Xi'An Taibo Electronic Technology Co., Ltd.)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252048",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:10.249Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:25.209Z",
      "change": {
        "note": "Clearance decision recorded",
        "at": "2026-02-03T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:70",
      "record": "Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)",
      "subtitle": "510(k) K253881",
      "detail": "Substantially Equivalent on 2025-12-29. Review panel: General, Plastic Surgery. Product code OHT.",
      "status": "Substantially Equivalent",
      "fields": {
        "recordType": "Device clearance",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "applicant": "Shenzhen Fansizhe Science and Technology Co., Ltd.",
        "productCode": "OHT",
        "kNumber": "K253881"
      },
      "jurisdiction": "US",
      "date": "2025-12-29T00:00:00.000Z",
      "dateType": "Decision date",
      "source": {
        "title": "FDA 510(k) clearance: Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) (Shenzhen Fansizhe Science and Technology Co., Ltd.)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253881",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:10.249Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:25.164Z",
      "change": {
        "note": "Clearance decision recorded",
        "at": "2025-12-29T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:71",
      "record": "IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)",
      "subtitle": "510(k) K253304",
      "detail": "Substantially Equivalent on 2025-11-25. Review panel: General, Plastic Surgery. Product code OHT.",
      "status": "Substantially Equivalent",
      "fields": {
        "recordType": "Device clearance",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "applicant": "Dongguan Lide Electric Appliance Co., Ltd.",
        "productCode": "OHT",
        "kNumber": "K253304"
      },
      "jurisdiction": "US",
      "date": "2025-11-25T00:00:00.000Z",
      "dateType": "Decision date",
      "source": {
        "title": "FDA 510(k) clearance: IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C) (Dongguan Lide Electric Appliance Co., Ltd.)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253304",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:10.249Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:25.136Z",
      "change": {
        "note": "Clearance decision recorded",
        "at": "2025-11-25T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:72",
      "record": "IPL Hair Removal Device (SYL001AZ, SYL002AZ)",
      "subtitle": "510(k) K253035",
      "detail": "Substantially Equivalent on 2025-11-19. Review panel: General, Plastic Surgery. Product code OHT.",
      "status": "Substantially Equivalent",
      "fields": {
        "recordType": "Device clearance",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "applicant": "Gu'An Yeolight Smart Electronics Co., Ltd.",
        "productCode": "OHT",
        "kNumber": "K253035"
      },
      "jurisdiction": "US",
      "date": "2025-11-19T00:00:00.000Z",
      "dateType": "Decision date",
      "source": {
        "title": "FDA 510(k) clearance: IPL Hair Removal Device (SYL001AZ, SYL002AZ) (Gu'An Yeolight Smart Electronics Co., Ltd.)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253035",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:10.249Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:25.104Z",
      "change": {
        "note": "Clearance decision recorded",
        "at": "2025-11-19T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:73",
      "record": "IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)",
      "subtitle": "510(k) K252618",
      "detail": "Substantially Equivalent on 2025-11-14. Review panel: General, Plastic Surgery. Product code OHT.",
      "status": "Substantially Equivalent",
      "fields": {
        "recordType": "Device clearance",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "applicant": "Alovea Healthcare Co. , Ltd.",
        "productCode": "OHT",
        "kNumber": "K252618"
      },
      "jurisdiction": "US",
      "date": "2025-11-14T00:00:00.000Z",
      "dateType": "Decision date",
      "source": {
        "title": "FDA 510(k) clearance: IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) (Alovea Healthcare Co. , Ltd.)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252618",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:10.249Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:25.075Z",
      "change": {
        "note": "Clearance decision recorded",
        "at": "2025-11-14T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:74",
      "record": "Diode Laser Hair Removal Machine (GLD01)",
      "subtitle": "510(k) K252427",
      "detail": "Substantially Equivalent on 2025-10-31. Review panel: General, Plastic Surgery. Product code GEX.",
      "status": "Substantially Equivalent",
      "fields": {
        "recordType": "Device clearance",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "applicant": "Sanhe Meditech Co., Ltd.",
        "productCode": "GEX",
        "kNumber": "K252427"
      },
      "jurisdiction": "US",
      "date": "2025-10-31T00:00:00.000Z",
      "dateType": "Decision date",
      "source": {
        "title": "FDA 510(k) clearance: Diode Laser Hair Removal Machine (GLD01) (Sanhe Meditech Co., Ltd.)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252427",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:10.249Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:25.046Z",
      "change": {
        "note": "Clearance decision recorded",
        "at": "2025-10-31T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:75",
      "record": "PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch",
      "subtitle": "510(k) K250275",
      "detail": "Substantially Equivalent on 2025-10-28. Review panel: General, Plastic Surgery. Product code GEI.",
      "status": "Substantially Equivalent",
      "fields": {
        "recordType": "Device clearance",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "applicant": "Baylis Medical Technologies, Inc.",
        "productCode": "GEI",
        "kNumber": "K250275"
      },
      "jurisdiction": "US",
      "date": "2025-10-28T00:00:00.000Z",
      "dateType": "Decision date",
      "source": {
        "title": "FDA 510(k) clearance: PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch (Baylis Medical Technologies, Inc.)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250275",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:10.249Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:25.013Z",
      "change": {
        "note": "Clearance decision recorded",
        "at": "2025-10-28T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:76",
      "record": "IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S)",
      "subtitle": "510(k) K252234",
      "detail": "Substantially Equivalent on 2025-10-14. Review panel: General, Plastic Surgery. Product code OHT.",
      "status": "Substantially Equivalent",
      "fields": {
        "recordType": "Device clearance",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "applicant": "Shenzhen Qiaochengli Technology Co., Ltd.",
        "productCode": "OHT",
        "kNumber": "K252234"
      },
      "jurisdiction": "US",
      "date": "2025-10-14T00:00:00.000Z",
      "dateType": "Decision date",
      "source": {
        "title": "FDA 510(k) clearance: IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S) (Shenzhen Qiaochengli Technology Co., Ltd.)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252234",
        "publisher": "U.S. Food and Drug Administration (510(k) database)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:10.249Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:24.983Z",
      "change": {
        "note": "Clearance decision recorded",
        "at": "2025-10-14T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    }
  ]
}