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510(k) Data Aggregation
K Number
K230351Device Name
LED Facial Mask
Manufacturer
Shenzhen SUNGPO HI-TECH Electronic Co., Ltd
Date Cleared
2023-05-05
(85 days)
Product Code
OHS, OLP
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen SUNGPO HI-TECH Electronic Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LED Facial Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
Device Description
The LED Facial Mask is an over-the-counter, facemask-shaped design light emitting diode (LED) device that emits light energy in the red, blue, and amber spectrum for the treatment of wrinkles or mild to moderate inflammatory acne on the face. The device consists of a mask body unit, controller, and AC adapter. The mask body unit contains light emitting diodes (LEDs) that emit visible red light (650nm+/-5nm), amber light (605nm+/-5nm), or blue light (465nm+/-5nm) to help reduce the appearance of wrinkles or mild to moderate acne. A controller is connected to the mask body unit to control the device, such as turn on/off the device, switch LED color output. An AC adapter is used to power the device. To use the device, user should place the mask body unit over the face and use the controller to operate. The device will automatically turn off after each treatment.
The LED Facial Mask includes MZ-01, NEWKEY-01, and SP-FM-01 models. Their intended use, performance, structure design, and operation are identical, with the difference being the product appearance, but these differences do not affect or change the intended use of the device.
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