N/A

GUDID 06976006415107

The LED Light Therapy Mask adopts light emitting diodes (LED) in the red (660nm±10nm) ,blue (415nm±10nm),yellow (590nm±10nm) and infrared (850nm±10nm) spectrum to irradiate on the face to realize its therapeutic effect. The LED Light Therapy Mask adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color), select energy level and start/pause light output. To use the device, user should place the mask over the face and use the controller to operate. The device will automatically turn off after each treatment. To prevent irradiation of LED lights to eyes during the treatment, LED Light Therapy Mask has incorporated protective eye-shield which blocks light energy from LEDs.

Shenzhen Sungrow LED Technology Co., LTD

Red/blue light phototherapy unit

• Primary Device ID: 06976006415107
• NIH Device Record Key: 6366181f-720d-49a7-8042-d1c12b150471
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: VISO
• Company DUNS: 402713443
• Company Name: Shenzhen Sungrow LED Technology Co., LTD
• Device Count: 1
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +8615219482246
• Email: sales2@sgrowled.com
• Phone: +8615219482246
• Email: sales2@sgrowled.com
• Phone: +8615219482246
• Email: sales2@sgrowled.com
• Phone: +8615219482246
• Email: sales2@sgrowled.com
• Phone: +8615219482246
• Email: sales2@sgrowled.com
• Phone: +8615219482246
• Email: sales2@sgrowled.com
• Phone: +8615219482246
• Email: sales2@sgrowled.com
• Phone: +8615219482246
• Email: sales2@sgrowled.com
• Phone: +8615219482246
• Email: sales2@sgrowled.com
• Phone: +8615219482246
• Email: sales2@sgrowled.com
• Phone: +8615219482246
• Email: sales2@sgrowled.com
• Phone: +8615219482246
• Email: sales2@sgrowled.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06976006415107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250830

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: 2025-08-21
• Device Publish Date: 2025-08-13

On-Brand Devices [N/A]

• 06976006415138: The LED Light Therapy Mask adopts light emitting diodes (LED) in the red (660nm±10nm) ,blue (41
• 06976006415121: The LED Light Therapy Mask adopts light emitting diodes (LED) in the red (660nm±10nm) ,blue (41
• 06976006415114: The LED Light Therapy Mask adopts light emitting diodes (LED) in the red (660nm±10nm) ,blue (41
• 06976006415107: The LED Light Therapy Mask adopts light emitting diodes (LED) in the red (660nm±10nm) ,blue (41
• 06976006415091: The LED Light Therapy Mask adopts light emitting diodes (LED) in the red (660nm±10nm) ,blue (41
• 06976006415084: The LED Light Therapy Mask adopts light emitting diodes (LED) in the red (660nm±10nm) ,blue (41
• 06976006415077: The LED Light Therapy Mask adopts light emitting diodes (LED) in the red (660nm±10nm) ,blue (41
• 06976006415060: The LED Light Therapy Mask adopts light emitting diodes (LED) in the red (660nm±10nm) ,blue (41
• 06976006415053: The LED Light Therapy Mask adopts light emitting diodes (LED) in the red (660nm±10nm) ,blue (41
• 06976006415046: The LED Light Therapy Mask adopts light emitting diodes (LED) in the red (660nm±10nm) ,blue (41
• 06976006415039: The LED Light Therapy Mask adopts light emitting diodes (LED) in the red (660nm±10nm) ,blue (41
• 06976006415022: The LED Light Therapy Mask adopts light emitting diodes (LED) in the red (660nm±10nm) ,blue (41
• 06976006415015: The LED Light Therapy Mask adopts light emitting diodes (LED) in the red (660nm±10nm) ,blue (41