Model: Pro450
DI: 06973337180025
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-09
Current Version: 2026-05-18
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
4c071368-8b25-49b7-b39c-fb10753aec97
Distribution Status:
In Commercial Distribution
DUNS Number:
551021000
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:
06973337180025
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 65723
Name: Red/infrared light phototherapy unit
Definition:
An electrically-powered device designed to emit red light and infrared/near-infrared light for phototherapy primarily to accelerate healing of cutaneous/mucosal tissues and/or to treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood flow. It may have various designs (e.g., hand-held, arched bar, flexible pad for adapting to body areas) and is intended for use in the home and clinical settings.
FDA Product Codes
OLI
Fat Reducing Low Level Laser
ILY
Lamp, Infrared, Therapeutic Heating
Premarket Submissions
Submission Number:
K252786
Supplement Number:
000