Identity
- Trade Name
- SOLAWAVE FDA UDI
- Generic Name
- Blue/red/infrared phototherapy lamp FDA UDI
- Device Name
- The Solawave 2-in-1 Skincare Mini (Model: 61043) is an over-the-counter device that emits energy in the red and infrared spectrum for treating wrinkles on the face and decolletage. FDA UDI
- Model / Reference
- 61043 FDA UDI
- Description
- The Solawave 2-in-1 Skincare Mini (Model: 61043) is an over-the-counter device that emits energy in the red and infrared spectrum for treating wrinkles on the face and decolletage. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810137610436 FDA UDI
- 510(k) Number
- K250532 FDA UDI
- FDA Product Code
- OHS FDA UDI
- GMDN Term
- Blue/red/infrared phototherapy lamp 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blue/red/infrared phototherapy lamp
Solawave by Shenzhen Kaiyan Medical Equipment Co, . Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blue/red/infrared phototherapy lamp.
- Dermalux — Aesthetic Technology, Ltd. · Class II
- 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
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
- Shenzhen Kaiyan Medical Equipment Co, . Ltd
Sources (1)
- FDA UDI 8c9f8552-fa90-4516-876a-f92aaaafc002 34 fields · synced Jun 6, 2026