Identity
- Trade Name
- Solawave FDA UDI
- Generic Name
- Cosmetic red-light phototherapy system, home-use FDA UDI
- Device Name
- The Radiant Renewal Skincare Wand (Model: HD-15A) is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use, the red light is intended for treating wrinkles on the face and is indicated for over-the-counter use. FDA UDI
- Model / Reference
- HD-15A FDA UDI
- Description
- The Radiant Renewal Skincare Wand (Model: HD-15A) is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use, the red light is intended for treating wrinkles on the face and is indicated for over-the-counter use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850035134887 FDA UDI
- 510(k) Number
- K232863 FDA UDI
- FDA Product Code
- NFO FDA UDIOHS FDA UDI
- GMDN Term
- Cosmetic red-light phototherapy system, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 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
Yes
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
Solawave by Shenzhen Kaiyan Medical Equipment Co, . Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K232863 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
- Shenzhen Kaiyan Medical Equipment Co, . Ltd
Sources (1)
- FDA UDI 2892412b-f53c-4869-8cf6-0655d0d4f025 34 fields · synced May 30, 2026