Model: 2
DI: 05060494130695
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
S2042 Red Laser
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
bb6eb74b-e4d6-4acf-89c0-ed502d4bb3ab
Distribution Status:
In Commercial Distribution
DUNS Number:
856233908
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:
05060494130695
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 45688
Name: Red-light phototherapy unit, professional
Definition:
An electrically-powered device designed to emit red light for phototherapy primarily to accelerate healing of cutaneous/mucosal wounds, treat mild skin disorders (e.g., mild acne), intraoral or nasal conditions, and/or treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood circulation. It is a non-wearable device which may be in the form of a hand-held, freestanding or mounted unit, and is intended to be used by a healthcare professional in a clinical setting.
FDA Product Codes
ILY
Lamp, Infrared, Therapeutic Heating
Premarket Submissions
Submission Number:
K033923
Supplement Number:
000