Identity
- Trade Name
- OXYLIGHT FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Device Name
- The OXYLIGHT System is a multi-modality skin surface treatment system that uses multiple therapeutic modalities delivered through different attachments or handles connected to a main body. The system includes an LED panel/ lamp that irradiates Blue, Red and Yellow LED light and Oxygen Spray. The system also includes various handles that deliver a variety of therapeutic modalities for skin rejuvenation. FDA UDI
- Model / Reference
- OXYLIGHT FDA UDI
- Description
- The OXYLIGHT System is a multi-modality skin surface treatment system that uses multiple therapeutic modalities delivered through different attachments or handles connected to a main body. The system includes an LED panel/ lamp that irradiates Blue, Red and Yellow LED light and Oxygen Spray. The system also includes various handles that deliver a variety of therapeutic modalities for skin rejuvenation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- G050OXYLIGHT0 FDA UDI
- FDA Product Code
- GEX FDA UDIGFE FDA UDI
- GMDN Term
- Multi-modality skin surface treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI878.4820 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
No
FDA UDI
Category: Multi-modality skin surface treatment system
Oxylight by RAJA Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K202175 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
- RAJA Medical
Sources (1)
- FDA UDI c81692eb-3aaf-4286-b5f7-75d94f0883e5 35 fields · synced May 31, 2026