Identity
- Trade Name
- Silk'n FDA UDI
- Generic Name
- Radio-frequency skin surface treatment system FDA UDI
- Device Name
- The Silk'n device ia an over-the-counter, non-invasive, non-ablative device utilizing RF and optical LED energies for the treatment of wrinkles. FDA UDI
- Model / Reference
- Titan FDA UDI
- Description
- The Silk'n device ia an over-the-counter, non-invasive, non-ablative device utilizing RF and optical LED energies for the treatment of wrinkles. FDA UDI
Identifiers
- Catalog Number
- 7290015763851 FDA UDI
- Primary DI / UDI-DI
- 17290015763858 FDA UDI
- 510(k) Number
- K162784 FDA UDI
- FDA Product Code
- PAY FDA UDIOHS FDA UDI
- GMDN Term
- Radio-frequency skin surface treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4420 FDA UDI878.4810 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: Radio-frequency skin surface treatment system
Silk'n 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
K162784 also covers:
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 |
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Manufacturer
- Manufacturer
- Home Skinovations , Ltd.
Sources (1)
- FDA UDI 7efe769b-af06-4242-be03-9585ea1bc1e4 37 fields · synced May 30, 2026