Identity
- Trade Name
- Silk'n FDA UDI
- Generic Name
- Medium-wave diathermy treatment system generator FDA UDI
- Device Name
- An over the counter, hand held device, intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles. FDA UDI
- Model / Reference
- Relief International FDA UDI
- Description
- An over the counter, hand held device, intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles. FDA UDI
Identifiers
- Catalog Number
- 7290016627138 FDA UDI
- Primary DI / UDI-DI
- 17290016627135 FDA UDI
- 510(k) Number
- K152087 FDA UDI
- FDA Product Code
- ILY FDA UDIGEI FDA UDI
- GMDN Term
- Medium-wave diathermy treatment system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 FDA UDI878.4400 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: Medium-wave diathermy treatment system generator
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
K152087 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 c5f14200-1a93-4882-95df-8c4632f2aea1 37 fields · synced May 30, 2026