AccessGUDID - DEVICE: LED Light Therapy Mask (16978368600020)

GUDID

Device Identifier (DI) Information

Brand Name: LED Light Therapy Mask
Version or Model: RB-008GB
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen Rainbow Technology Co.,Ltd

Primary DI Number: 16978368600020
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 550663864 *Terms of Use

Device Description: - Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Blue light: Treatment of mild to moderate inflammatory acne. The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62202	Blue/red/infrared phototherapy lamp	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHS	Light Based Over The Counter Wrinkle Reduction
OLP	Over-The-Counter Powered Light Based Laser For Acne
ILY	Lamp, Infrared, Therapeutic Heating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K243423	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 219e759a-0728-4e47-bdb6-145b36edc1a9
Public Version Date: June 13, 2025
Public Version Number: 1
DI Record Publish Date: June 05, 2025