Identity
- Trade Name
- Celluma FDA UDI
- Generic Name
- Blue/red/infrared phototherapy lamp FDA UDI
- Device Name
- 2 mode small panel light therapy device FDA UDI
- Model / Reference
- Series 2 HOME C/US FDA UDI
- Description
- 2 mode small panel light therapy device FDA UDI
Identifiers
- Catalog Number
- CPM2-001 FDA UDI
- Primary DI / UDI-DI
- 00850523007747 FDA UDI
- FDA Product Code
- OHS FDA UDIILY FDA UDI
- GMDN Term
- Blue/red/infrared phototherapy lamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI890.5500 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
No
FDA UDI
MR Unsafe FDA UDI
Category: Blue/red/infrared phototherapy lamp
Celluma by BioPhotas, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K152280 also covers:
K171323 also covers:
- Celluma — BioPhotas, Inc.
- Celluma — BioPhotas, Inc.
- Celluma — BioPhotas, Inc.
- Celluma — BioPhotas, Inc.
- Celluma — BioPhotas, Inc.
- Celluma — BioPhotas, Inc.
- Celluma — BioPhotas, Inc.
- Celluma — BioPhotas, Inc.
- Celluma — BioPhotas, Inc.
- Celluma — BioPhotas, Inc.
- Celluma — BioPhotas, Inc.
- Celluma — BioPhotas, Inc.
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
- BioPhotas, Inc.
Sources (1)
- FDA UDI 3cbc35ee-c2ad-4e01-8c08-14ab5bec279f 35 fields · synced May 30, 2026