Identity
- Trade Name
- Genesis Skye FDA UDI
- Generic Name
- Blue-light phototherapy lamp, home-use FDA UDI
- Device Name
- Over the counter blue LED phototherapy device for the treatment of acne. FDA UDI
- Model / Reference
- GSKYE FDA UDI
- Description
- Over the counter blue LED phototherapy device for the treatment of acne. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850001456647 FDA UDI
- FDA Product Code
- OLP FDA UDI
- GMDN Term
- Blue-light phototherapy lamp, home-use 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
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
MR Conditional FDA UDI
Category: Blue-light phototherapy lamp, home-use
Genesis Skye by Omm Imports Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Omm Imports Inc.
Sources (1)
- FDA UDI 6deb488c-052e-414a-8cfe-55b82ce29c29 34 fields · synced Jun 1, 2026