Identity
- Trade Name
- Celluma FDA UDI
- Generic Name
- Blue/red/infrared phototherapy lamp FDA UDI
- Device Name
- 3 Panel 5 Mode Low Level Light Therapy Device FDA UDI
- Model / Reference
- Series 2 CONTOUR PLUS FDA UDI
- Description
- 3 Panel 5 Mode Low Level Light Therapy Device FDA UDI
Identifiers
- Catalog Number
- CT5M-001 FDA UDI
- Primary DI / UDI-DI
- 00850075326006 FDA UDI
- FDA Product Code
- ILY FDA UDIOHS FDA UDIOAP FDA UDIOLI FDA UDI
- GMDN Term
- Blue/red/infrared phototherapy lamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 FDA UDI878.4810 FDA UDI878.5400 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
Yes
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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Also classified as Blue/red/infrared phototherapy lamp.
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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.
K232977 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BioPhotas, Inc.
Sources (1)
- FDA UDI eaa03f0d-f550-4990-b2be-49615a45fd84 35 fields · synced May 29, 2026