N/A

Primary DI
06976006415053
Brand
N/A
Company
Shenzhen Sungrow LED Technology Co., LTD
Model
G11
Device description
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.
Published
2025-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHSLight Based Over The Counter Wrinkle Reduction
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2
OLPOver-The-Counter Powered Light Based Laser For AcneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250830000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250830000LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)Shenzhen Sungrow Led Technology Co., Ltd.2025-06-09OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976006415053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976006415053069760064150536976006415053

GMDN Terms#

Term, Definition table
TermDefinition
Red/blue light phototherapy unitA portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. This is a single-patient, reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+8615219482246sales2@sgrowled.com

Regulatory Flags#

DUNS number
402713443
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976006415015N/AG152025-08-13
06976006415022N/AG15P2025-08-13
06976006415039N/AG15K2025-08-13
06976006415046N/AG11P2025-08-13
06976006415060N/A G102025-08-13
06976006415077N/AG132025-08-13
06976006415084N/AG142025-08-13
06976006415091N/AG172025-08-13
06976006415107N/AVISO2025-08-13
06976006415114N/APRANA2025-08-13
06976006415121N/AChin2Chest2025-08-13
06976006415138N/ABBL-FACEMASK2025-08-13
06976006410010sgrow LED Therapy LightE24002024-11-13

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