NPHLA Tracker · Aesthetic device clearances (FDA 510(k))
Aesthetic Device Clearances (FDA 510(k))
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.
- Pending editorial review
A system check is an automated check of the official sources, not a human review. An editorial review is recorded only when one of our editors has reviewed the page.
- Records
- 20
- Changed in 7 days
- 0
- Latest record
- Jurisdiction
- United States (federal)
Records
20 records| Record | Status | Applicant | Product code | Jurisdiction | Date | Source | Last checked |
|---|---|---|---|---|---|---|---|
| Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)510(k) K262524Substantially Equivalent on 2026-09-18. Review panel: General, Plastic Surgery. Product code OHT. | Substantially Equivalent | ONE BEAUTY Technology Co., Ltd. | OHT | United States (federal) | Decision date | U.S. Food and Drug Administration (510(k) database): 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.) (opens in a new tab)Official record | System checked NPHLA updated |
| Hair Removal Device (R3C16-G Pro, R3C16-V Pro)510(k) K261705Substantially Equivalent on 2026-08-10. Review panel: General, Plastic Surgery. Product code OHT. | Substantially Equivalent | Shenzhen Jianchao Intelligent Technology Co., Ltd. | OHT | United States (federal) | Decision date | U.S. Food and Drug Administration (510(k) database): FDA 510(k) clearance: Hair Removal Device (R3C16-G Pro, R3C16-V Pro) (Shenzhen Jianchao Intelligent Technology Co., Ltd.) (opens in a new tab)Official record | System checked NPHLA updated |
| Diode laser hair removal machine (QDTM-04)510(k) K261693Substantially Equivalent on 2026-07-17. Review panel: General, Plastic Surgery. Product code GEX. | Substantially Equivalent | Beijing Nubway S&T Co., Ltd. | GEX | United States (federal) | Decision date | U.S. Food and Drug Administration (510(k) database): FDA 510(k) clearance: Diode laser hair removal machine (QDTM-04) (Beijing Nubway S&T Co., Ltd.) (opens in a new tab)Official record | System checked NPHLA updated |
| Intense Pulsed Light Therapy Device510(k) K261204Substantially Equivalent on 2026-06-12. Review panel: General, Plastic Surgery. Product code ONF. | Substantially Equivalent | Sanhe LEFIS Electronics Co., Ltd. | ONF | United States (federal) | Decision date | U.S. Food and Drug Administration (510(k) database): FDA 510(k) clearance: Intense Pulsed Light Therapy Device (Sanhe LEFIS Electronics Co., Ltd.) (opens in a new tab)Official record | System checked NPHLA updated |
| Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)510(k) K261325Substantially Equivalent on 2026-05-21. Review panel: General, Plastic Surgery. Product code OHT. | Substantially Equivalent | Shenzhen Ulike Smart Electronics Co., Ltd. | OHT | United States (federal) | Decision date | U.S. Food and Drug Administration (510(k) database): 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.) (opens in a new tab)Official record | System checked NPHLA updated |
| 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)510(k) K260594Substantially Equivalent on 2026-05-20. Review panel: General, Plastic Surgery. Product code OHT. | Substantially Equivalent | Shenzhen Xiazhifeng Electronic Co., Ltd. | OHT | United States (federal) | Decision date | U.S. Food and Drug Administration (510(k) database): 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.) (opens in a new tab)Official record | System checked NPHLA updated |
| AYON Body Contouring System (AYON SYSTEM)510(k) K253396Substantially Equivalent on 2026-05-08. Review panel: General, Plastic Surgery. Product code QPB. | Substantially Equivalent | Apyx Medical Corporation | QPB | United States (federal) | Decision date | U.S. Food and Drug Administration (510(k) database): FDA 510(k) clearance: AYON Body Contouring System (AYON SYSTEM) (Apyx Medical Corporation) (opens in a new tab)Official record | System checked NPHLA updated |
| Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)510(k) K260742Substantially Equivalent on 2026-05-05. Review panel: General, Plastic Surgery. Product code OHT. | Substantially Equivalent | Shenzhen Ulike Smart Electronics Co., Ltd. | OHT | United States (federal) | Decision date | U.S. Food and Drug Administration (510(k) database): 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.) (opens in a new tab)Official record | System checked NPHLA updated |
| 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)510(k) K260518Substantially Equivalent on 2026-04-21. Review panel: General, Plastic Surgery. Product code OHT. | Substantially Equivalent | Shenzhen Semlamp Intelligent Technology Co., Ltd. | OHT | United States (federal) | Decision date | U.S. Food and Drug Administration (510(k) database): 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.) (opens in a new tab)Official record | System checked NPHLA updated |
| Disposable Radiofrequency Cannula510(k) K253907Substantially Equivalent on 2026-04-16. Review panel: Neurology. Product code GXI. | Substantially Equivalent | ABBOTT MEDICAL | GXI | United States (federal) | Decision date | U.S. Food and Drug Administration (510(k) database): FDA 510(k) clearance: Disposable Radiofrequency Cannula (ABBOTT MEDICAL) (opens in a new tab)Official record | System checked NPHLA updated |
| 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)510(k) K254047Substantially Equivalent on 2026-03-11. Review panel: General, Plastic Surgery. Product code OHT. | Substantially Equivalent | Shenzhen Chuangtong Yigou Technology Co., Ltd. | OHT | United States (federal) | Decision date | U.S. Food and Drug Administration (510(k) database): 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.) (opens in a new tab)Official record | System checked NPHLA updated |
| IPL Hair Removal Device (Models: T31A, T32A)510(k) K253666Substantially Equivalent on 2026-02-23. Review panel: General, Plastic Surgery. Product code OHT. | Substantially Equivalent | Shenzhen Mlay Intelligent Technology Co., Ltd. | OHT | United States (federal) | Decision date | U.S. Food and Drug Administration (510(k) database): FDA 510(k) clearance: IPL Hair Removal Device (Models: T31A, T32A) (Shenzhen Mlay Intelligent Technology Co., Ltd.) (opens in a new tab)Official record | System checked NPHLA updated |
| 808nm semiconductor laser hair removal machine510(k) K252048Substantially Equivalent on 2026-02-03. Review panel: General, Plastic Surgery. Product code GEX. | Substantially Equivalent | Xi'An Taibo Electronic Technology Co., Ltd. | GEX | United States (federal) | Decision date | U.S. Food and Drug Administration (510(k) database): FDA 510(k) clearance: 808nm semiconductor laser hair removal machine (Xi'An Taibo Electronic Technology Co., Ltd.) (opens in a new tab)Official record | System checked NPHLA updated |
| Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)510(k) K253881Substantially Equivalent on 2025-12-29. Review panel: General, Plastic Surgery. Product code OHT. | Substantially Equivalent | Shenzhen Fansizhe Science and Technology Co., Ltd. | OHT | United States (federal) | Decision date | U.S. Food and Drug Administration (510(k) database): 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.) (opens in a new tab)Official record | System checked NPHLA updated |
| IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)510(k) K253304Substantially Equivalent on 2025-11-25. Review panel: General, Plastic Surgery. Product code OHT. | Substantially Equivalent | Dongguan Lide Electric Appliance Co., Ltd. | OHT | United States (federal) | Decision date | U.S. Food and Drug Administration (510(k) database): 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.) (opens in a new tab)Official record | System checked NPHLA updated |
| IPL Hair Removal Device (SYL001AZ, SYL002AZ)510(k) K253035Substantially Equivalent on 2025-11-19. Review panel: General, Plastic Surgery. Product code OHT. | Substantially Equivalent | Gu'An Yeolight Smart Electronics Co., Ltd. | OHT | United States (federal) | Decision date | U.S. Food and Drug Administration (510(k) database): FDA 510(k) clearance: IPL Hair Removal Device (SYL001AZ, SYL002AZ) (Gu'An Yeolight Smart Electronics Co., Ltd.) (opens in a new tab)Official record | System checked NPHLA updated |
| IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)510(k) K252618Substantially Equivalent on 2025-11-14. Review panel: General, Plastic Surgery. Product code OHT. | Substantially Equivalent | Alovea Healthcare Co. , Ltd. | OHT | United States (federal) | Decision date | U.S. Food and Drug Administration (510(k) database): FDA 510(k) clearance: IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) (Alovea Healthcare Co. , Ltd.) (opens in a new tab)Official record | System checked NPHLA updated |
| Diode Laser Hair Removal Machine (GLD01)510(k) K252427Substantially Equivalent on 2025-10-31. Review panel: General, Plastic Surgery. Product code GEX. | Substantially Equivalent | Sanhe Meditech Co., Ltd. | GEX | United States (federal) | Decision date | U.S. Food and Drug Administration (510(k) database): FDA 510(k) clearance: Diode Laser Hair Removal Machine (GLD01) (Sanhe Meditech Co., Ltd.) (opens in a new tab)Official record | System checked NPHLA updated |
| PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch510(k) K250275Substantially Equivalent on 2025-10-28. Review panel: General, Plastic Surgery. Product code GEI. | Substantially Equivalent | Baylis Medical Technologies, Inc. | GEI | United States (federal) | Decision date | U.S. Food and Drug Administration (510(k) database): FDA 510(k) clearance: PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch (Baylis Medical Technologies, Inc.) (opens in a new tab)Official record | System checked NPHLA updated |
| 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)510(k) K252234Substantially Equivalent on 2025-10-14. Review panel: General, Plastic Surgery. Product code OHT. | Substantially Equivalent | Shenzhen Qiaochengli Technology Co., Ltd. | OHT | United States (federal) | Decision date | U.S. Food and Drug Administration (510(k) database): 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.) (opens in a new tab)Official record | System checked NPHLA updated |
How is this tracker compiled?
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.
Selection: Official records (device clearance) from primary sources.
What does it cover?
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.
What are its 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.
How often is it updated?
Checked about every 12 hours, as configured in the Source Registry.
System checked is the last time an automated check of the underlying official sources succeeded — it is not a human review. Editorially reviewed appears only when an editor has reviewed this tracker. Each row shows its own check: an automated system check or an editor’s verification.
Data origin: NPHLA analysis of public data. Professional reference only — not medical, legal or regulatory advice. Always confirm a record in its primary source. Spotted an error? Tell us.