Model: kks-281
DI: 06980088700020
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Sterilization
Method Types - Sterilization Method:
Liquid Chemical
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
929daccd-a255-423c-8a52-dd3fe6a864d2
Distribution Status:
In Commercial Distribution
DUNS Number:
546984470
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
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:
06980088700020
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
Premarket Submissions
Submission Number:
K254007
Supplement Number:
000