LED Light Therapy Mask

GUDID 06978368600030

- 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.

Shenzhen Rainbow Technology Co.,Ltd

Blue/red/infrared phototherapy lamp
Primary Device ID06978368600030
NIH Device Record Key1a2af019-19ec-4466-9bd3-7a912a1eeacf
Commercial Distribution StatusIn Commercial Distribution
Brand NameLED Light Therapy Mask
Version Model NumberRB-008J
Company DUNS550663864
Company NameShenzhen Rainbow Technology Co.,Ltd
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106978368600030 [Unit of Use]
GS116978368600037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OHSLight Based Over The Counter Wrinkle Reduction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-13
Device Publish Date2025-06-05

On-Brand Devices [ LED Light Therapy Mask]

06978368600818- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrink
06978368600306- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrink
06978368600030- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrink
06978368600023- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrink
06978368600016- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrink

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.