TheraClear 40-TC116-00.AA
TheraClear 40-TC116-00.AA is a medical device (FDA Class II; FDA product code ONF, Powered Light Based Non-Laser Surgical Instrument With Thermal Effect) made by Theravant Corporation, cleared under FDA 510(k) K123889 on 4 Mar 2013 and listed in FDA GUDID since 14 Feb 2017 (UDI-DI B305THERACLEAR10), 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 | NumberB305THERACLEAR10 | Date14 Feb 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123889 | Date4 Mar 2013 | StatusActive |
Official records
- FDA 510(k) database K123889
Across registries
- FDA 510(k) K123889 decided 4 Mar 2013 Active
- FDA GUDID UDI-DI B305THERACLEAR10 listed 14 Feb 2017 Listed
Timeline
- Cleared FDA 510(k) K123889
- Listed FDA GUDID B305THERACLEAR10
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- TheraClear
- Generic name
- Multi-modality skin surface treatment system generator
- Model / Ref / Catalog
- 40-TC116-00.AA, 40-TC116
- Primary DI / UDI-DI
- B305THERACLEAR10
- 510(k) Number
- FDA product code
- ONF
- GMDN term
- Multi-modality skin surface treatment system generator
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution