Model: BRLB01
DI: 06978213840338
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-21
Current Version: 2026-05-29
Description
Lower Back Red Light Therapy Device
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a3a6783b-935a-4cfc-a23b-2db96c534079
Distribution Status:
In Commercial Distribution
DUNS Number:
553073906
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06978213840338
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 62202
Name: Blue/red/infrared phototherapy lamp
Definition:
A portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.
FDA Product Codes
ILY
Lamp, Infrared, Therapeutic Heating