Identity
- Trade Name
- Silk'n FDA UDI
- Generic Name
- Blue/red/infrared phototherapy lamp FDA UDI
- Device Name
- LED Light Therapy Mask FDA UDI
- Model / Reference
- FM-02 FDA UDI
- Description
- LED Light Therapy Mask FDA UDI
Identifiers
- Catalog Number
- 7290019840046 FDA UDI
- Primary DI / UDI-DI
- 17290019840043 FDA UDI
- 510(k) Number
- K223544 FDA UDI
- FDA Product Code
- OHS FDA UDIOLP FDA UDIILP FDA UDI
- GMDN Term
- Blue/red/infrared phototherapy lamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI890.3700 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: Blue/red/infrared phototherapy lamp
Silk'n by Silk'N Beauty , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blue/red/infrared phototherapy lamp.
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- Celluma — BioPhotas, Inc. · Class II
- reVive Light Therapy® — LED TECHNOLOGIES, INC. · Class II
- Dr Dennis Gross Skincare — LED TECHNOLOGIES, INC. · Class II
- LESCOLTON — Shenzhen Lescolton Medical Equipment Co., Ltd. · Class II
- Platinum LED Therapy Lights — PLATINUM LED HOLDINGS LLC · Class II
- LESCOLTON — Shenzhen Lescolton Medical Equipment Co., Ltd. · Class II
- Platinum LED Therapy Lights — PLATINUM LED HOLDINGS LLC · Class II
Cleared under the same submission
K223544 also covers:
- AURA — Guangdong Newdermo Biotech Co., Ltd.
- AURA — Guangdong Newdermo Biotech Co., Ltd.
- INIA — Guangdong Newdermo Biotech Co., Ltd.
- Newdermo — Guangdong Newdermo Biotech Co., Ltd.
- VOGUENOW — Guangdong Newdermo Biotech Co., Ltd.
- VOGUENOW — Guangdong Newdermo Biotech Co., Ltd.
- WONDER FAMILY — Guangdong Newdermo Biotech Co., Ltd.
- WONDER FAMILY — Guangdong Newdermo Biotech Co., Ltd.
- kingdo — Guangdong Newdermo Biotech Co., Ltd.
- kingdo — Guangdong Newdermo Biotech Co., 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
- Silk'N Beauty , Ltd.
Sources (1)
- FDA UDI 266d8522-3bc1-47bd-908b-6418c2e7f200 36 fields · synced May 30, 2026