FDA UDI In Commercial Distribution 🇺🇸 United States

Celluma

DI: 00850523007754 · Model: Series 2 FACE C/US · Biophotas, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Celluma
Primary DI
00850523007754
Version / Model
Series 2 FACE C/US
Catalog Number
CLF2-001
Company Name
Biophotas, Inc.
Labeler DUNS
063400364
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-12-23
Public Version
2
Public Version Date
2025-07-25
Public Version Status
Update
Public Device Record Key
2b6b3030-6c86-4ecd-9550-a8a620c6a77c

Device Description

2 mode small panel

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
OLP Over-The-Counter Powered Light Based Laser For Acne
OHS Light Based Over The Counter Wrinkle Reduction

GMDN Terms

Code Name
62202 Blue/red/infrared phototherapy lamp

Identifiers

Type ID
Primary 00850523007754