LED Light Therapy Mask - HIME SAMA

GUDID 06978368600054

- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles. - Blue light: Treatment of mild to moderate inflammatory acne.

Shenzhen Rainbow Technology Co.,Ltd

Blue/red/infrared phototherapy lamp

• Primary Device ID: 06978368600054
• NIH Device Record Key: 593b938f-7af2-4e67-98fd-f72ac035420e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LED Light Therapy Mask - HIME SAMA
• Version Model Number: RB-008
• 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	06978368600054 [Unit of Use]
GS1	16978368600051 [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

• 06978368600108 - LED Light Therapy Mask: 2026-02-16 *Red+Infrared light: Treatment of full-face wrinkles. *Red light: Treatment of full-face wrinkles. *Infrared light: Provide to
• 16978368600105 - LED Light Therapy Mask: 2026-02-16 *Red+Infrared light: Treatment of full-face wrinkles. *Red light: Treatment of full-face wrinkles. *Infrared light: Provide to
• 06978368600160 - LED Light Therapy Mask: 2026-02-16 *Red+Infrared light: Treatment of full-face wrinkles. *Red light: Treatment of full-face wrinkles. *Infrared light: Provide to
• 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 m