PHILIPS Lumea Comfort SC1981
PHILIPS Lumea Comfort SC1981 (075020040312) is a Class II device made by Home Skinovations, Ltd., cleared under FDA 510(k) K141242 on 17 Oct 2014 and listed in FDA GUDID since 15 Aug 2016 (UDI-DI 10075020040319), 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 | Number10075020040319 | Date15 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK141242 | Date17 Oct 2014 | StatusActive |
Official records
- AccessGUDID record 10075020040319
- FDA 510(k) database K141242
Across registries
- FDA 510(k) K141242 decided 17 Oct 2014 Active
- FDA GUDID UDI-DI 10075020040319 listed 15 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K141242
- Listed FDA GUDID 10075020040319
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Philips
- Generic name
- Cosmetic red-light phototherapy system, home-use
- Model / Ref / Catalog
- Lumea Comfort SC1981, 075020040312
- Primary DI / UDI-DI
- 10075020040319
- 510(k) Number
- FDA product code
- ONF, OHT
- 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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