Identity
- Trade Name
- OMNILUX FDA UDI
- Generic Name
- Musculoskeletal/physical therapy laser, professional FDA UDI
- Device Name
- OMNILUX MEDICAL REVIVE2 HEAD FDA UDI
- Model / Reference
- EM1654 FDA UDI
- Description
- OMNILUX MEDICAL REVIVE2 HEAD FDA UDI
Identifiers
- Primary DI / UDI-DI
- B434EM1654 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Musculoskeletal/physical therapy laser, professional 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
Yes
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
Yes
FDA UDI
Category: Musculoskeletal/physical therapy laser, professionalSkin photodynamic therapy/phototherapy lamp
Omnilux by Lotus Global Group, Inc, The — 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
- Lotus Global Group, Inc, The
Sources (1)
- FDA UDI 11d50d03-a41e-4480-943e-60df1b426c1c 33 fields · synced Jun 6, 2026