Model: S900
DI: 00850001456784
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-03
Current Version: 2026-05-11
Distribution End: 2035-07-14
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
67062e0f-d1c4-4b26-869d-b453b8ae23c0
Distribution Status:
In Commercial Distribution
DUNS Number:
010000704
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850001456784
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
OHS
Light Based Over The Counter Wrinkle Reduction
ILY
Lamp, Infrared, Therapeutic Heating