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510(k) Data Aggregation
(88 days)
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(57 days)
The Led Light Therapy Device (Model:SG-FSM) is an Over-the-Counter medical device intended for treatment of wrinkles in the face and decolletage area.
- Red light: Treatment of wrinkles.
- Red+Infrared Light: Treatment of wrinkles.
- Amber light: Treatment of wrinkles.
- Amber+Infrared Light: Treatment of wrinkles.
The Led Light Therapy Device (Model:SG-NK) is an Over-the-Counter medical device intended for treatment of wrinkles in the decolletage area.
- Red light: Treatment of wrinkles.
- Red+Infrared Light: Treatment of wrinkles.
- Amber light: Treatment of wrinkles.
- Amber+Infrared Light: Treatment of wrinkles.
The Led Light Therapy Device (Model:SG-CT) is an Over-the-Counter medical device intended for treatment of wrinkles in the decolletage area.
- Red light: Treatment of wrinkles.
- Red+Infrared light: Treatment of wrinkles.
- Infrared light: Provide topical heating for the purpose of elevating tissue temperature, and to temporarily increase local blood circulation.
The Led Light Therapy Device is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles.
LED Light Therapy Device(Model:SG-FSM) is consisting of Flexible silicone panel (LED mask and upper chest), controller, silicone eye protector, USB charging cable and straps.
LED Light Therapy Device(Model:SG-NK, SG-CT) is consisting of Flexible silicone panel (upper chest), controller, USB charging cable and straps.
The LED Light Therapy Device(Model:SG-FSM) have 3 types of light, which include Red light (wavelength 630nm), Infrared light (wavelength 850nm for LED mask, wavelength 830nm for upper chest) and Amber light (wavelength 605nm).
The LED Light Therapy Device(model:SG-NK) have 3 types of light, which include Red light (wavelength 630nm), Infrared light (wavelength 830nm) and Amber light (wavelength 605nm).
The LED Light Therapy Device (Model:SG-CT) have 2 types of light, which include Red light (wavelength 630nm) and Infrared light (wavelength 830nm).
The LED Light Therapy Device is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components.
The device operates on an internal lithium rechargeable battery. The rechargeable battery can be charged from the external charging adapter through the provided USB Charging Cable. The USB charging cable is only used for charging, and the device cannot be used while charging.
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(90 days)
CEC101:
Microcurrent Facial Device is intended for facial stimulation for over-the-counter aesthetic use.
The light treatment of Microcurrent Facial Device is indicated for:
- Red light is intended for the treatment of facial wrinkles.
- Blue light is intended for the treatment of mild to moderate inflammatory acne.
EEI101:
Microcurrent Facial Device is intended for facial, neck and body skin stimulation for over-the-counter aesthetic use.
The light treatment of Microcurrent Facial Device is indicated for:
- Red light is intended for the treatment of facial wrinkles.
- Blue light is intended for the treatment of mild to moderate inflammatory acne.
- Mixed light (Red and Blue) is intended for the treatment of mild to moderate inflammatory acne.
The Microcurrent Facial Device probe is designed for optimal contact with the face. The device has two different microcurrent modes that differ in how the probe switches. Users can adjust settings for personalized comfort by pressing the mode button. The microcurrent mode intensity starts from (0) to (9).(Cleared under K244004)
The device also outputs blue light with the wavelength of 415+/-10nm and red light with the wavelength 622+/-10nm and delivers to the skin of the face to achieve the therapeutic effects，such as improving mild to moderate acne on the face.
The Microcurrent Facial Devices unit contains a main board and a rechargeable battery. The enclosure is made of medical-grade biocompatible plastic and the probe is made of irregularly shaped stainless steel.
Model CEC101 have "Phototherapy mode", "CLEANING mode","PENETRATION mode", "LIFTING mode" and "COOL mode" five modes. The "CLEANING mode","PENETRATION mode", "LIFTING mode" and "COOL mode" modes have cleared under K244004.
Model EEI101 have "Phototherapy mode", "Face mode", "Neck mode", and "Body mode" four modes. The "Face mode", "Neck mode", and "Body mode" have cleared under K244004.
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(112 days)
The LED Beauty Mask is an over-the-counter device that is intended for use in the treatment of full-face wrinkles.
This product is based on low-energy red light therapy (LED Phototherapy), which achieves through precise wavelength control:
Wavelength selection: Using 630 red light and 830nm near-infrared light to treat wrinkle for 25-50 years women
The main body of the mask is made of medical-grade silicone, with a total weight of ≤300g, and an elastic headband, which can be worn for a long time without pressure.
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VITA Multi-Function Head Brush is an Over-The-Counter (OTC) device.
Head Mode: The device is indicated to promote hair growth in male with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V and females with androgenic aplopecia who have Ludwig-Savin Classification of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.
Face Mode:
LED therapy function: The device is indicated for the treatment of full face wrinkles and/or mild to moderate inflammatory acne.
The VITA Multi-Function Head Brush is a hand-held device. It consists of a host, a removable treatment head, and a charging cable. The host has a button, indicator lights, and the device's power-on/off, treatment mode switch can be achieved by pressing the button. The removable treatment head has lights row, stainless steel bristles and liquid reservoir (applicable for model TB-2443F/ TB-2442AF), of which the liquid reservoir is used for the hair care after treatment.
The LEDs and low-level lasers in the removable treatment head emit light on the treatment area. In addition, the device is also equipped with a built-in micro motor to generates micro-vibration to relax the facial skin. The device has a head mode and face mode, and the device will automatically shut down after each mode completes treatment within 10 minutes. The device is powered by a built-in rechargeable lithium battery.
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(88 days)
The MEGELIN LED Light Therapy Mask is an Over-the-Counter (OTC) light based device.
- Red light: Treatment of full-face wrinkles.
- Blue light (only suitable model JML1, JML3, JML5, JML6, JML9 Face mask): Treatment of mild to moderate inflammatory acne.
The MEGELIN LED Light Therapy Mask uses blue light (460nm) to treat acne. The MEGELIN LED Light Therapy Mask uses red light (660nm) to irradiate on the facial skin that help reduce wrinkles.
JML1, JML3, JML5, JML6, JML9 are face masks, with the only difference in energy density setting, while JML2, JML4, JML7, JML8, JML10 are neck masks with the only difference in energy density setting.
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