Luma Revive TN2189
Luma Revive TN2189 is a cosmetic red-light phototherapy system (FDA Class II; FDA product code OHS, Light Based Over The Counter Wrinkle Reduction) made by iSMART Developments, Ltd., cleared under FDA 510(k) K231555 on 27 Jul 2023 and listed in FDA GUDID since 26 Oct 2023 (UDI-DI 05060534510692), 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 | Number05060534510692 | Date26 Oct 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK231555 | Date27 Jul 2023 | StatusActive |
Official records
- AccessGUDID record 05060534510692
- FDA 510(k) database K231555
Across registries
- FDA 510(k) K231555 decided 27 Jul 2023 Active
- FDA GUDID UDI-DI 05060534510692 listed 26 Oct 2023 Listed
Timeline
- Cleared FDA 510(k) K231555
- Listed FDA GUDID 05060534510692
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Luma Revive
- Generic name
- Cosmetic red-light phototherapy system, home-use
- Model / reference
- TN2189
- Primary DI / UDI-DI
- 05060534510692
- 510(k) Number
- FDA product code
- OHS
- GMDN term
- Cosmetic red-light phototherapy system, home-use
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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