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510(k) Data Aggregation
(88 days)
The device is an over the counter device that is intended for:
- Red+Infrared light: Treatment of full-face wrinkles;
- Red+Blue+Infrared light: Treatment of mild to moderate inflammatory acne;
- Yellow+Infrared light: Treatment of full-face wrinkles.
The LED Light Therapy Mask (Models: M19, M19-1, M19-2, M19-3, M19-5, M19-6) is an Over-the-Counter (OTC), home-use, wearable LED phototherapy device, and intended for the use of treating full-face wrinkles and mild to moderate acne. Light radiates from the inner surface of the device onto the face. This light is generated by LED with four different spectrum wavelengths: red (660nm), infrared (850nm), yellow (590nm) and blue (460nm). The LED Light Therapy Mask is consisting of main unit (mask), controller and USB charging cable. The device is powered by rechargeable Li-battery and controlled by a controller that is connected to the main unit. The device's power-on/off, mode switch, intensity adjustment and time adjustment can be operated by the controller. The device will automatically shut down when the treatment time is over.
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(105 days)
The Light Therapy Mask is an over-the-counter device intended for the treatment of full-face wrinkles and mild to moderate inflammatory acne using LED light therapy.
- Red light: Treatment of full-face wrinkles.
- Blue light: Treatment of mild to moderate inflammatory acne.
- Red+Infrared Light: Treatment of full-face wrinkles.
- Mixed light (Red+Blue+Infrared): Treatment of mild to moderate inflammatory acne.
The subject device Light Therapy Mask is a home use wearable LED phototherapy device whose purpose is to produce an even and narrow-band of light for the treatment of aesthetic indications including facial wrinkles and acnes.
The subject device consists of a mask body unit that contains light emitting diodes (LEDs), a controller, straps and USB-C charging cable. And the device is powered by built-in rechargeable lithium battery on the controller.
The LEDs generate 3 kinds of light which include Red light (wavelength 635nm±5nm), Blue light (wavelength 465nm±5nm), Infrared light (wavelength 850nm±5nm). A controller is connect to the mask body unit to control the device, such as turn on/off the device. And the straps used for securing the mask unit to the body part.
The device have vibration function, and user can adjust the vibration intensity. Vibration is for general relaxation purposes.
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