10PL-H/P
10PL-H/P is a Class II device made by Tentech Co., Ltd., cleared under FDA 510(k) K220794 on 10 Nov 2022 and listed in FDA GUDID since 28 Jun 2024 (UDI-DI 08809709380435), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08809709380435 | Date28 Jun 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK220794 | Date10 Nov 2022 | StatusActive |
Official records
- AccessGUDID record 08809709380435
- FDA 510(k) database K220794
Across registries
- FDA 510(k) K220794 decided 10 Nov 2022 Active
- FDA GUDID UDI-DI 08809709380435 listed 28 Jun 2024 Listed
Timeline
- Cleared FDA 510(k) K220794
- Listed FDA GUDID 08809709380435
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- 10PL
- Generic name
- Intense pulsed light skin surface treatment system
- Model / reference
- 10PL-H/P
- Primary DI / UDI-DI
- 08809709380435
- 510(k) Number
- FDA product code
- ONF
- GMDN term
- Intense pulsed light skin surface treatment system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect).
- Forma Light FS60000 by FORMATK SYSTEMS LTD
- L-650 FS90015 by FORMATK SYSTEMS LTD
- 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.