10PL-Body
10PL-Body 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 08809709380411), 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 | Number08809709380411 | Date28 Jun 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK220794 | Date10 Nov 2022 | StatusActive |
Official records
- AccessGUDID record 08809709380411
- FDA 510(k) database K220794
Across registries
- FDA 510(k) K220794 decided 10 Nov 2022 Active
- FDA GUDID UDI-DI 08809709380411 listed 28 Jun 2024 Listed
Timeline
- Cleared FDA 510(k) K220794
- Listed FDA GUDID 08809709380411
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- Withdrawn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-Body
- Primary DI / UDI-DI
- 08809709380411
- 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
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