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510(k) Data Aggregation
(60 days)
Model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808:
Facial & Body Beauty Device is a hand-held device for over-the counter aesthetic purposes.
- The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation.
- The Photon mode: The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne.
Model: INIA-ED001, INIA-ED002, INIA-BLD001, E1507:
Facial & Body Beauty Device is a hand-held device for over-the counter aesthetic purposes.
- The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation;
- The Photon mode: The red light is intended for the treatment of periorbital wrinkles.
Facial & Body Beauty Device is portable, non-sterile and reusable device, which is designed to achieve the aesthetic effect. The device mainly consists of a main unit and charging cable, and it is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the provided charging cable, but the device can not be used when charging.
The device is for home environment use, which has electrodes for microcurrent stimulation (the microcurrent stimulation mode was cleared under K252553) and light emitting diodes for light therapy treatment. Especially, the light therapy function of the device equips both red light (for wrinkles treatment) and blue light (for acne treatment) for model INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, while equips only red light for model INIA-ED001, INIA-ED002, INIA-BLD001, E1507.
To use the device, user should place the treatment head on the face and body (only applicable for microcurrent stimulation mode). The device will automatically shut down after treatment time is over.
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(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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(60 days)
*Red+Infrared light: Treatment of full-face wrinkles.
*Red light: Treatment of full-face wrinkles.
*Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm;relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
*Blue light: Treatment of mild to moderate inflammatory acne.
*Red+Blue light: Treatment of mild to moderate inflammatory acne.
The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.
LED Light Therapy Mask (Model: RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) is a home use wearable LED phototherapy device which can help reduce wrinkles and acne and provide topical heating. LED Light Therapy Mask is consisting of main unit(mask), controller, Type-C charging cable and so on. There are 3 kinds of light, which include Red light (wavelength 630nm), Blue light (wavelength 465nm), Infrared light (wavelength 850nm). All models can output 5 kinds of treatment modes: red+infrared, red, infrared, blue and red+blue light.
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(85 days)
a. Red light: Treatment of full-face wrinkles.
b. Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness, promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
c. Amber light: Treatment of full-face wrinkles.
d. Blue light: Treatment of mild to moderate inflammatory acne.
The subject device LED LIGHT THERAPY FACE 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 charging cable. And the device is powered by built-in rechargeable lithium battery on the controller.
The LEDs generate 4 kinds of light which include 460nm±5nm blue light, 630±5nm and 660nm±5nm red light, 850±5nm near-infrared light, 605±5nm amber light. A controller is connect to the mask body unit to control the device, such as turn on/off the device, switch LED mode output. And the straps used for securing the mask unit to the body part.
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(86 days)
Feather/numiere 05 06 07 (05) is an Over the-Counter (OTC) device intended for the use in treating wrinkles on the decolletage.
Feather/ numiere 05 06 07 (Models: 05) is an over-the-counter light-emitting diode (LED) device that emits energy for the treatment of wrinkles. The device works by simultaneously emitting 630nm±10nm, 830nm ±10nm wavelengths for the treatment of wrinkles on the neck and decolletage (upper chest). The device is designed in a flexible silicone panel that contains red (630nm±10nm) and near infrared (830nm±10nm) light-emitting diodes (LEDs). The device also contains a controller that controls the power on and off of the device, and regulates the intensity of the treatment by pressing buttons, and the controller
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(89 days)
For model:HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HGMZ-2W-G1V1,HGMZ-2W-G2V1
The LED LIGHT THERAPY MASK is an Over-the-Counter (OTC) light based device
Red light: Treatment of full- face wrinkles (only model HHGMZ-2W-G1V1, HGMZ-2W-G2V1).
Blue light: Treatment of mild to moderate inflammatory acne. (only suitable model HLGMZ-3W-G1V1 and HLGMZ-3W-G2V1)
Mixed light(Red+NIR light): Treatment of full face wrinkles (Model: HLGMZ-3W-G1V1, HLGMZ-3W-G2V1)
For model:HLG-GJXJ-G1V1,MRD-GJXJ-G1V1
The Led Light Therapy for Neck is an Over-the-Counter (OTC) light based device
Red light: Treatment of neck wrinkles (Model: MRD-GJXJ-G1V1)
Mixed light(Red+NIR light): Treatment of neck wrinkles (Model: HLG-GJXJ-G1V1)
The LED Light Therapy Device is a home-use phototherapy device designed to provide targeted treatment for skin conditions using specific wavelengths of light. The device incorporates advanced LED technology to deliver red (660nm), near-infrared (850nm), and blue (415nm) light. This combination of wavelengths is intended to address two primary skin concerns: full-face wrinkles and mild to moderate inflammatory acne.
Significant Physical and Performance Characteristics:
• Design: The device features a lightweight and ergonomic design, making it comfortable to wear. It includes adjustable head straps and eye pads to ensure a secure and comfortable fit during treatment.
• Materials: The device is constructed from high-quality, durable materials, including nylon fabric and clear silicone, ensuring safety and comfort during use.
• Performance: The device includes 74 LEDs, each with a 3-in-1 chip structure (660nm + 415nm + 850nm), providing dual-mode functionality (Red and Blue Light or Red+IR and Blue light). It offers three adjustable brightness levels (L1-L5) and three timing options (10, 15, 20 minutes) to customize the treatment according to user needs.
• Power Supply: The device is powered by a 5V 2A adapter, with an input voltage range of 100-240V 50/60Hz, ensuring compatibility with various power sources worldwide.
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(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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(87 days)
The Led Light Therapy Device (Model: SG-FM) is an Over-the-Counter medical device intended for treatment of wrinkles and mild to moderate inflammatory acne.
- Red light: Treatment of wrinkles.
- Red+Infrared Light: Treatment of wrinkles.
- Amber light: Treatment of wrinkles.
- Blue Light: Treatment of mild to moderate inflammatory acne.
The Led Light Therapy Device (Model: SG-FE) is an Over-the-Counter medical device intended for treatment of wrinkles.
- 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 and mild to moderate inflammatory acne. LED Light Therapy Device is consisting of LED mask, controller, silicone eye protector, USB charging cable and straps.
The LED Light Therapy Device (Model:SG-FM) have 4 types of light, which include Red light (wavelength 630nm), Blue light (wavelength 460nm), Infrared light (wavelength 850nm), and Amber light (wavelength 605nm).
The LED Light Therapy Device (Model:SG-FE) have 2 types of light, which include Red light (wavelength 630nm) and Infrared light (wavelength 850nm).
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)
The Wrinkle Retreat Pro Light Therapy Face Mask is an Over-the-Counter (OTC) device intended for use in treating full-face wrinkles.
The Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) adopts light emitting diodes (LED) in amber(605nm±5nm), red (630nm±5nm), red (660nm±5nm) and near-infrared (830nm±5nm) spectrum to irradiate on the face to realize its therapeutic effect. The Wrinkle Retreat Pro Light Therapy Face 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 to turn on/off the device. 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, this Mask has incorporated protective eye-shield which blocks light energy from LEDs. The Mask is powered by a built-in rechargeable lithium battery which is located in the controller.
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(81 days)
ACNE mode (red light + blue light): Treatment of mild to moderate inflammatory acne.
FIRM mode (yellow light): Treatment of full-face wrinkles.
WRINKLE mode (red light + IR light): Treatment of full-face wrinkles.
The LED Therapy Mask (Models: SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) 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 (630nm), infrared (830nm), yellow (590nm) and blue (415nm). The LED Therapy Mask is consisting of main unit (mask, including eye shield), controller, USB charging cable and head strap.
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 can be operated by the controller. The device will automatically shut down when the treatment time is over.
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