FDA UDI In Commercial Distribution 🇺🇸 United States

FAQ Dual LED Panel

DI: 07640260120617 · Model: Black · Foreo AB
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
FAQ Dual LED Panel
Primary DI
07640260120617
Version / Model
Black
Company Name
Foreo AB
Labeler DUNS
352394143
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-03-02
Public Version
1
Public Version Date
2026-03-10
Public Version Status
New
Public Device Record Key
bc4d84b9-83a6-4f98-9847-99218ef6566a

Device Description

FAQ LED Panels are over-the-counter (OTC) devices intended for the treatment of wrinkles with red+ infrared light and yellow + infrared light, and the treatment of mild to moderate acne with blue+infrared light.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

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

GMDN Terms

Code Name
62202 Blue/red/infrared phototherapy lamp

Identifiers

Type ID
Primary 07640260120617