TheraClear TC40
TheraClear TC40 is an intense pulsed light skin surface treatment system (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by STRATA Skin Sciences, Inc, cleared under FDA 510(k) K101415 on 8 Jul 2010 and listed in FDA GUDID since 6 Mar 2025 (UDI-DI M709THCLR01), 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 | NumberM709THCLR01 | Date6 Mar 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK101415 | Date8 Jul 2010 | StatusActive |
Official records
- FDA 510(k) database K101415
Across registries
- FDA 510(k) K101415 decided 8 Jul 2010 Active
- FDA GUDID UDI-DI M709THCLR01 listed 6 Mar 2025 Listed
Timeline
- Cleared FDA 510(k) K101415
- Listed FDA GUDID M709THCLR01
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- TheraClear
- Generic name
- Intense pulsed light skin surface treatment system
- Model / reference
- TC40
- Primary DI / UDI-DI
- M709THCLR01
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Intense pulsed light skin surface treatment system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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