IPL Therapy Machine
by Beijing ADSS Development Co., Ltd.
510(k) K161286
IPL Therapy Machine is a medical device (FDA Class II; FDA product code ONF, Powered Light Based Non-Laser Surgical Instrument With Thermal Effect) made by Beijing ADSS Development Co., Ltd., cleared under FDA 510(k) K161286 on 4 Aug 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK161286 | Date4 Aug 2016 | StatusActive |
Official records
- FDA 510(k) database K161286
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ONF
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K161286
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Ipl Therapy Machine VE2000 | VE2000 | 06970453270043 | On the market | |
| WORLD AESTHETIX BROAD PULSED LIGHT WAX161286 | WAX161286 | 00850062978003 | No longer on the market |
Similar devices
Other devices filed under FDA product code ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect).
- IPL THERAPY SYSTEM by Beijing Starlight Science & Technology Development
- MULTIFUNCTIONAL SERIES by BEIJING HONKON TECHNOLOGIES CO., LTD.
- TRIOS SYSTEM by VIORA LTD
- Shiny RPL System by IDS LTD.
- A-TONE IPL SYSTEM by Ybk Investment, Inc.
- SR580 applicator AS120032 by Venus Concept Inc.
- SR515 applicator AS120033 by Venus Concept Inc.
- IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650 by Shanghai Apolo Medical Technologies Co., Ltd.
- INTENSE PULSED LIGHT (IPL) SYSTEMS by Beijing KES Biology Technology Co.,Ltd.
- Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 by Shenzhen Ionka Medical Technology Co., Ltd.