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510(k) Data Aggregation

    K Number
    K242068
    Device Name
    LED Light Therapy Mask (RT01)
    Manufacturer
    Ningbo Dechang Electrical Machinery Made Co.,Ltd
    Date Cleared
    2025-04-04

    (263 days)

    Product Code
    OLP, OHS
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    OLP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LED Light Therapy Mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LED Light Therapy Mask is an over-the-counter device intended to emit energy in the red and Near Infrared spectrum and is intended for the use in the treatment of full-face wrinkles.
    Device Description
    The LED Light Therapy Mask is a home use wearable light emitting diode (LED) phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full-face wrinkles and mild to moderate acne vulgaris of the face. The system consists of a Face mask and a controller. The Face mask contains the light emitting diodes (LEDs). The LEDs generate the light. The mask is worn on the face and is held in place by adjustable head strap. The LEDs produce blue, red and near infra-red (NIR) light in the visible spectrum (Blue: 415nm +/- 10nm, Red: 630nm +/- 10nm, NIR 830nm +/-10nm.). The controller allows the user to select one of two treatment modes (acne or wrinkles) and switches the LEDs ON/OFF, controlling power to the mask. The modes can be selected by short pressing the Power/mode button. The controller contains a countdown timer and counts down from 10 minutes. The user may stop the treatment during the 10 minutes by long pressing Power/mode button. The controller contains a rechargeable Lithium-ion polymer battery. The controller uses a Power indicator to show the user the battery power level during working status and the charge status during charging. The Power adapter and power cable are used to charge the Lithium battery. The power cable is also used to connect the controller and face mask during working status. The LED Light Therapy Mask cannot be operated while charging. The LED Light Therapy Mask includes optional heating pads for the lower eyelids, providing localized thermal comfort within a temperature range of 38℃~41℃. The heating function is controlled via the controller and does not interfere with the treatment of acne or wrinkles.
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    K Number
    K243555
    Device Name
    LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)
    Manufacturer
    Shenzhen Eyco Technology Co., Ltd
    Date Cleared
    2025-02-05

    (79 days)

    Product Code
    OLP, OHS
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    OLP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Mode 1 (Red + Infrared light): treatment of full face wrinkles. - Mode 2 (Blue light): Treatment of mild to moderate inflammatory acne. - Mode 3 (Mixed light): Treatment of mild to moderate inflammatory acne.
    Device Description
    LED phototherapy masks are over-the-counter light-emitting diode (LED) devices that emit energy and are used in dermatology to treat acne and wrinkles. The device emits red (630nm) and infrared (850nm) light to treat wrinkles and blue (415nm) light to treat mild to moderate acne. All models had to be fitted with an eye mask and strapped to the treatment area, and all had a controller to set the parameters of the device. There are 10 models of the device (model: E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A), all of which are operated through a controller.
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    K Number
    K232656
    Device Name
    BLU TOTALE (Model: ENEOB852)
    Manufacturer
    Premier North America Inc.
    Date Cleared
    2023-11-14

    (75 days)

    Product Code
    OLP
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    OLP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BLU TOTALE is an over the counter phototherapy device for use in dermatology for the treatment of mild to moderate acne.
    Device Description
    BLU TOTALE is a battery-operated device that uses low power light spectrum at blue LED, at wavelength of 415 ±15nm emitting optical power in a uniform distribution with no hot spots. It is a hand held light emitting diode (LED) device for the treatment of acne designed for home-use.
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    K Number
    K230490
    Device Name
    PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT
    Manufacturer
    Dongguan Hunter Electronic Technology Co., Ltd.
    Date Cleared
    2023-10-27

    (246 days)

    Product Code
    OLP
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    OLP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The pmd clean acne is intended for over-the-counter use to treat mild to moderate inflammatory acne.
    Device Description
    The pmd clean acne adopts light emitting diodes (LED) in the blue (415nm ± 5nm) spectrum to irradiate on the face to realize its therapeutic effect. The pmd clean acne adopts handheld design, LEDs are contained in the blue light treatment window, and on its reverse side, the soft silicone bristols can be used to clean the face before the blue light treatment. The product is provided with internal battery and it can be charged by external adaptor. To prevent irradiation of LED lights to eyes during the treatment, pmd clean acne is equipped with goggles which blocks light energy from LEDs.
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    K Number
    K230720
    Device Name
    LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001
    Manufacturer
    Light Tree Ventures Europe B.V.
    Date Cleared
    2023-07-03

    (109 days)

    Product Code
    OLP
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    OLP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LUSTRE 3XPRESS Light Beauty Therapy patches (Model: PR6001, PR5001) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
    Device Description
    The LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001 and PR5001 is an over-the-counter light emitting diode (LED) device that emits energy to treat mild to moderate acne. The device uses two types of LEDs: 415 nm and 630nm. The LUSTRE 3XPRESS Light Beauty Therapy patches components include the device containing two Light Beauty Therapy Patches, an USB Cable with an integrated controller, 120 Mini Dots, a Goggles, a Travel pouch and a User Manual. Among them, mini dots are used for fixed device, goggles are used to protect eyes, and travel pouch are used to store device. There is a total of 24 LEDs for each model to provide a power intensity of about 30 mw/cm². The user pastes the device on the treatment area, and the device will shut down automatically after a 3minute after finishing treatment. The two models are only different in shape. PR6001 is triangular and PR5001 is crescent.
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    K Number
    K213056
    Device Name
    LED Facial Mask
    Manufacturer
    Shenzhen OSTO Technology Company Limited
    Date Cleared
    2022-07-07

    (288 days)

    Product Code
    OLP, OHS
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    OLP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LED Facial Mask is an over the counter device. The Red light mode is intended for the treatment of periorbital wrinkles. The Red and Infrared light combination mode is intented for the treatment of full-face wrinkles. The blue light is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only.
    Device Description
    LED Facial Mask (Model: AST-804, AST-804A, AST-804B, AST-805, AST-805A, AST-805B)
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    K Number
    K220729
    Device Name
    The Luminance RED Acne Device
    Manufacturer
    Luminance Medical Ventures, Inc.
    Date Cleared
    2022-06-09

    (87 days)

    Product Code
    OLP
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    OLP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Luminance RED Acne Device is intended to enit energy in the spectrum, and is specifically indicated to treat mild to moderate acne.
    Device Description
    The Luminance RED Acne Device is a lightweight, handheld device that consists of a body handle and treatment head. The body handle contains 2 LEDs that emit visible blue light (415 nm +/- 10 nm) or visible red light (660 nm +/- 10 nm) through the treatment head to help reduce the appearance of mild to moderate acne. The body consists of a plastic shell which includes a button to turn the device on/off, a button for red visible light, a button for blue visible light, and a digital countdown timer. The Luminance RED Acne Device is powered by a lithium-ion battery.
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    K Number
    K213039
    Device Name
    Micro-current facial cold and hot service (model: TPML-100)
    Manufacturer
    Li-Tek Electronics Technology C0., Ltd
    Date Cleared
    2022-05-25

    (245 days)

    Product Code
    OLP, NFO
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    OLP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Micro-current vibration facial cold and hot service is an over the counter device that is indicated for the treatment of mild to moderate inflammatory acne and facial stimulation for the over the counter aesthetic use.
    Device Description
    The Micro-current vibration facial cold and hot service device (Model: TPML-100) is a hand-held, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, and USB cable. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the USB cable. The device is un-usable when charging. The device is only home environment use, which has three metal heads (Dual / Single), and two LED light windows (Red / Blue) to provides following functions: a) EMS (micro current output stimulation) function. The device generates a low-frequency micro-current on the Dual Heads which will applied in the facial skin to do facial stimulation. b) Red and Blue LED irradiation function. The device outputs the red light at the wavelength of 630 ± 10 nm and the blue light at the wavelength of 415 ± 10 nm to apply the light in narrow spectral bandwidth on facial skin to treat mild to moderate acne. c) Vibration function. The device generates different patterns of micro-vibration by a builtin micro motor to relax the facial skin. (This function is classified as class I and not need for 510K.) d) Warming and Cooling function. The device heats Dual Heads up to 44 ± 2 °C or cool the Single Head down to 10 ± 2 °C, to relax the facial skin with a warm or cold sensation. (This function is not for medical purpose.)
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    K Number
    K210545
    Device Name
    Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine
    Manufacturer
    Marci Beauty Inc
    Date Cleared
    2022-05-20

    (449 days)

    Product Code
    OLP, OHS
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    OLP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infrared Red Blue LED Light Heat Beauty Machine is an hand-held over-the-counter phototherapy device, the red and infrared light is intended for the use in treating wrinkles on the face and the blue light is intended for the treatment of the mild to moderate inflammatory acne. This device is indicated for adults only.
    Device Description
    The proposed device Infrared Red Blue LED Light Heat Beauty Machine, is a over-the-counter device hat uses low power light spectrum at red blue and infrared LED, at wavelength of 625±5nm, 465mm, 850±5nm emitting optical power in a uniform distribution. The device is composed of a handpiece for delivery of light energy, base unit for charging and storage when not in use, and A.C.charging adapter. It is a hand-held light emitting diode (LED) device for treatment of wrinkles on face and mild to moderate inflammatory acne designed for home use.
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    K Number
    K214103
    Device Name
    Shani Darden LED light therapy mask
    Manufacturer
    Harpar Grace International
    Date Cleared
    2022-03-22

    (83 days)

    Product Code
    OLP, OHS
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    OLP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Shani Darden LED light therapy mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The Shani Darden LED light therapy mask is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.
    Device Description
    The Shani Darden LED light therapy mask is a home use wearable light emitting diode phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full-face wrinkles and mild to moderate acne vulgaris of the face. The system consists of a hard-shell mask and a controller. The mask is worn on the face and is held in place by an adjustable Velcro strap. The LEDs produce blue, red and near infra-red (NIR) light in the visible spectrum (Blue: 415nm +/- 10nm, Red: 630nm +/- 10nm, NIR 830nm +/-10nm.). The device works by emitting the specified wavelengths into the skin in order to improve the appearance of wrinkles or to target bacteria that can cause acne vulgaris. The controller allows the user to select one of three treatment programmes (acne and wrinkles) and switches the LEDs ON/OFF, controlling power to the mask. The controller contains a simple graphical user interface (GUI) and three control buttons. The mask receives its power from a mains power adaptor.
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