Celluma MYSTIQUE
Celluma MYSTIQUE (CFM-001) is a Class II device made by BioPhotas, Inc., listed in FDA GUDID since 6 Apr 2026 (UDI-DI 00850523007365), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850523007365 | Date6 Apr 2026 | StatusListed |
Official records
- AccessGUDID record 00850523007365
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Celluma
- Generic name
- Blue/red/infrared phototherapy lamp
- Model / Ref / Catalog
- MYSTIQUE, CFM-001
- Primary DI / UDI-DI
- 00850523007365
- FDA product code
- OAP, OHS, OLP
- GMDN term
- Blue/red/infrared phototherapy lamp
- Device class
- Class II
- Regulation number
- 890.5500, 878.4810
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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