LED Light Therapy Mask

GUDID 06978368600047

- 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 ID: 06978368600047
• NIH Device Record Key: 89f84f2c-95b6-4942-ad1a-a6e2f3a2160e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LED Light Therapy Mask
• Version Model Number: RB-008JB
• Company DUNS: 550663864
• Company Name: Shenzhen Rainbow Technology Co.,Ltd
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06978368600047 [Unit of Use]
GS1	16978368600044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243423

FDA Product Code

• OHS: Light Based Over The Counter Wrinkle Reduction

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-13
• Device Publish Date: 2025-06-05

Devices Manufactured by Shenzhen Rainbow Technology Co.,Ltd

• 06978368600085 - LED Light Therapy Mask-GYH: 2025-06-26 Red+Infrared light:Treatment of full-face wrinkles. Red light:Treatment of full-face wrinkles. Blue light:Treatment of mild to m
• 06978368600016 - LED Light Therapy Mask: 2025-06-13 - Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles - Blue light: Treatment of m
• 06978368600023 - LED Light Therapy Mask: 2025-06-13 - Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles - Blue light: Treatment of m
• 06978368600030 - LED Light Therapy Mask: 2025-06-13 - Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles - Blue light: Treatment of m
• 06978368600047 - LED Light Therapy Mask: 2025-06-13- 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.
• 06978368600047 - LED Light Therapy Mask: 2025-06-13 - Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles - Blue light: Treatment of m
• 06978368600054 - LED Light Therapy Mask - HIME SAMA: 2025-06-13 - Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles. - Blue light: Treatment of
• 16978368600082 - LED Light Therapy Mask-GYH: 2025-06-13 Red+Infrared light:Treatment of full-face wrinkles. Red light:Treatment of full-face wrinkles. Blue light:Treatment of mild to m
• 06978368600306 - LED Light Therapy Mask: 2025-06-13 - Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles. - Infrared light: Provide t