Identity
- Trade Name
- Solar Wave 24 220V FDA UDI
- Generic Name
- Ultraviolet tanning device FDA UDI
- Device Name
- THE DEVICE IS AN OVER-THE-COUNTER TANNING DEVICE EMITTING ULTRAVIOLET LIGHT IN HTE UVB AND UVA REGION OF THE SPECTRUM INTENDED FOR TANNING THE HUMAN SKIN OF AN ADULT PERSON. FDA UDI
- Model / Reference
- SW24 220V FDA UDI
- Description
- THE DEVICE IS AN OVER-THE-COUNTER TANNING DEVICE EMITTING ULTRAVIOLET LIGHT IN HTE UVB AND UVA REGION OF THE SPECTRUM INTENDED FOR TANNING THE HUMAN SKIN OF AN ADULT PERSON. FDA UDI
Identifiers
- Catalog Number
- SW24 220V FDA UDI
- Primary DI / UDI-DI
- G710SW24220V0 FDA UDI
- 510(k) Number
- K180576 FDA UDI
- FDA Product Code
- LEJ FDA UDI
- GMDN Term
- Ultraviolet tanning device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4635 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ultraviolet tanning device
Solar Wave 24 220V by Sunshine Usa, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K180576 also covers:
- AVALON 16 — SUNSHINE USA, LLC
- AVALON 20 — SUNSHINE USA, LLC
- AVALON 24 — SUNSHINE USA, LLC
- AVALON 28 — SUNSHINE USA, LLC
- AVALON 32 — SUNSHINE USA, LLC
- GALAXY 16 — SUNSHINE USA, LLC
- GALAXY 18 — SUNSHINE USA, LLC
- GALAXY 22 — SUNSHINE USA, LLC
- GALAXY 24 — SUNSHINE USA, LLC
- GALAXY 30 — SUNSHINE USA, LLC
- OASIS 36 — SUNSHINE USA, LLC
- SOLAR STORM 24C — SUNSHINE USA, LLC
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
- Sunshine Usa, Llc
Sources (1)
- FDA UDI 465afdd6-b1e5-4c32-8d98-648c5523f502 35 fields · synced May 30, 2026