Identity
- Trade Name
- Luminance RED Acne Device FDA UDI
- Generic Name
- Red/blue light phototherapy unit FDA UDI
- Model / Reference
- TN1927D FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860002593036 FDA UDI
- 510(k) Number
- K220729 FDA UDI
- FDA Product Code
- OLP FDA UDI
- GMDN Term
- Red/blue light phototherapy unit 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Red/blue light phototherapy unit
Luminance RED Acne Device by Luminance Medical Ventures Incorporated — 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
- Luminance Medical Ventures Incorporated
Sources (1)
- FDA UDI 07c78af3-249d-4036-851d-7ce843d40973 33 fields · synced Jun 8, 2026