Identity
- Trade Name
- PHILIPS FDA UDI
- Generic Name
- Cosmetic red-light phototherapy system, home-use FDA UDI
- Device Name
- An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime. FDA UDI
- Model / Reference
- Lumea Comfort SC1981 FDA UDI
- Description
- An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime. FDA UDI
Identifiers
- Catalog Number
- 075020040312 FDA UDI
- Primary DI / UDI-DI
- 10075020040319 FDA UDI
- 510(k) Number
- K141242 FDA UDI
- FDA Product Code
- ONF FDA UDIOHT FDA UDI
- GMDN Term
- Cosmetic red-light phototherapy system, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cosmetic red-light phototherapy system, home-use
Philips by Home Skinovations , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K141242 also covers:
- Remington — Home Skinovations , Ltd.
- Silk'n — Home Skinovations , Ltd.
- Silk'n — Home Skinovations , Ltd.
- Silk'n — Home Skinovations , Ltd.
- Silk'n — Home Skinovations , Ltd.
- Silk'n — Home Skinovations , Ltd.
- Silk'n — Home Skinovations , Ltd.
- Silk'n — Home Skinovations , Ltd.
- Silk'n — Home Skinovations , Ltd.
- Silk'n — Home Skinovations , Ltd.
- Silk'n — Home Skinovations , Ltd.
- Silk'n — Silk'N Beauty , Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Home Skinovations , Ltd.
Sources (1)
- FDA UDI d79fce18-af1b-4893-a182-28141ceaf391 37 fields · synced Jun 1, 2026