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510(k) Data Aggregation
(163 days)
The HIGHERDOSE BODY SCULPTOR (Model: GS-03) is an over-the-counter device that is intended to improve the appearance of wrinkles.
The HIGHERDOSE Body Sculptor (Model: GS-03) is a home-use light-emitting diode phototherapy device with two proven wavelengths of light 650nm Red light and 850nm Near infrared red light, both of these lights are known to reducing the wrinkle.
The main device is made of black plastic (ABS+PC) and silicone button cup, and contain light emitting diode (LED) which will emit red light and infrared light. The device is a handheld device.
The device contains a rechargeable Lithium battery, which can be charged by charging disk. The HIGHERDOSE Body Sculptor cannot be operated while charging.
Press and hold the power button to turn the product on/off. Press the power button briefly to turn the LED light therapy on/off.
The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.
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(63 days)
The device are indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
The Aduro Hair Growth (Model: M-130) is a device designed to be used with a baseball cap that emits led light with the intention to promote hair growth. The device provides distributed led to the scalp at 660nm±10nm. The device is designed as a head-mounted product, and it consists of the main unit, a controller and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device has only one key for switching on and off the device and it will automatically shut down after a 10-minute treatment is completed.
The Trudermal Halo Hair growth system (Model: M-180A) is a device designed to be used with a baseball cap that emits led light with the intention to promote hair growth. The device provides distributed led to the scalp at 660nm±10nm. The device is designed as a head-mounted product, and it consists of the main unit, a controller and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device has only one key for switching on and off the device and it will automatically shut down after a 10-minute treatment is completed.
The Aduro Hair Growth (Model: M-300) is a device designed to be used with a baseball cap that emits led light and Laser with the intention to promote hair growth. The device provides distributed led and laser to the scalp at 650nm (±10nm). The device is designed as a head-mounted product, and it consists of the main unit, a controller and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device has only one key for switching on and off the device and it will automatically shut down after a 25-minute treatment is completed.
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(85 days)
KALA MINI 2.0 (Model: KALA-04) (Mode 1) is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
KALA MINI 2.0 (Model: KALA-04) (Mode 2) is an over-the counter device intended for the treatment of full-face wrinkles.
The KALA MINI 2.0 (Model: KALA-04) is a home use light-emitting diode phototherapy device with four proven wavelengths of red light: 630nm, 660nm, and near infrared red light: 830nm, 850nm, the red light (630nm, 660nm) are known to treat the wrinkles and the NIR light (830nm, 850nm) to provide topical heating to elevate tissue temperature for the temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain or muscle spasms and to provide a temporary increase in local blood circulation.
The equipment is a panel that contains LEDs. There are two buttons, one LED display screen on this panel: the button used to control the treatment time and the irradiance of the device; the LED display screen will show the remaining treatment time. Beside the buttons, there are power indicator which will indicate the remaining battery power.
There are fixed straps on the back of the panel, which you can use to hold the panel in your hand. The surfaces patients will contact with hand are constructed of silicone.
The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and be connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The KALA MINI 2.0 (Model: KALA-04) cannot be operated while charging. The cable for connecting with the controller is detachable.
The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.
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