LED Light Therapy Mask

GUDID 06978368600818

- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles. - Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Blue light: Treatment of mild to moderate inflammatory acne

Shenzhen Rainbow Technology Co.,Ltd

Blue/red/infrared phototherapy lamp

• Primary Device ID: 06978368600818
• NIH Device Record Key: 54dd3de7-20d4-46f5-bcf7-58c917481cd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LED Light Therapy Mask
• Version Model Number: RB-081
• 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	06978368600818 [Unit of Use]
GS1	16978368600815 [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

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