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510(k) Data Aggregation

    K Number
    K250224
    Device Name
    handLITE (TN19S)
    Manufacturer
    iSMART Developments LTD
    Date Cleared
    2025-04-18

    (81 days)

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

    ONE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The handLITE is intended to emit energy in the red and near infrared region of the light spectrum, is generally indicated to treat dermatological conditions and specifically indicated to treat contact dermatitis of the hand and wrist.
    Device Description
    The handLITE device consists of: 1. Flexible silicone glove with integrated controller (contains rechargeable lithium-ion polymer battery) 2. Power supply and country specific adaptors handLITE is a home use wearable light emitting diode (LED) phototherapy device. The device consists of a flexible silicone glove that contains red (630nm) and near infrared (830nm) light emitting diodes (LEDs) and an integrated controller. The LEDs generate the light at an intensity of 30mW/cm², delivering 18J/cm² per treatment. The power supply is used to charge the integrated Lithium battery in the handLITE.
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    K Number
    K171055
    Device Name
    Philips BlueControl
    Manufacturer
    Philips Electronics Nederland B.V.
    Date Cleared
    2017-07-06

    (87 days)

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

    ONE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Philips BlueControl is intended to emit energy in the blue region of the spectrum, is generally indicated to treat dermatological conditions and specifically indicated to treat mild psoriasis vulgaris.
    Device Description
    The Philips BlueControl is a rechargeable battery-operated, wearable device for delivery of blue light to treat mild psoriasis vulgaris. It is a prescription device designed for home use. The Philips BlueControl is sold as a kit, which contains the following items: Components: o BlueControl Device o Fixation Strap (Device Holder and Slings) o Power Supply (USB Cable, Adapter and Charger) Accessory: ● 0 Carrying Case Instructions for Use.
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    K Number
    K103415
    Device Name
    TANDA MAX
    Manufacturer
    PHAROS LIFE CORPORATION
    Date Cleared
    2011-01-03

    (42 days)

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

    ONE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tända Max System is intended for the treatment of wrinkles, rhytides and fine lines in the periorbital region.
    Device Description
    Tända Max is a modular system that offers simplicity in use and convenience. The system can operate while connected directly to an electrical outlet or can be used in cordless mode drawing upon its rechargeable batteries to deliver the treatment. The system components include the control unit, the treatment head, recharging stand, Pre-treatment gel, AC adapter and goggles. Tända Max utilizes red light at 660 nm. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The surface that comes into contact with the skin has been selected to ensure the light is administered to the skin while providing a smooth surface for cleaning.
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    K Number
    K100628
    Device Name
    PLASMALUXLS
    Manufacturer
    DAAVLIN DISTRIBUTING CO.
    Date Cleared
    2010-11-24

    (264 days)

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

    ONE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PlasmaLuxLS is a medical light source, which is intended for use for the treatment of moderate acne vulgaris with blue light. The PlasmaLuxLS is a medical laser device, which is intended for the treatment of moderate inflammatory acne vulgaris.
    Device Description
    The PlasmaLuxLS is a compact light source that delivers a uniform distribution of light, with spectral output at peak wavelengths of 417 nm (Blue Light) a It is intended for use by or under the direction of a physician for the treatment of moderate acne vulgaris with blue light. The desired dose is selected using the operator interface located on the front panel of the device. The PlasmaLux LS device delivers local area phototherapy, whereby lamps deliver the specified dose of Blue Light.
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    K Number
    K091467
    Device Name
    BABY QUASAR
    Manufacturer
    SILVER BAY, LLC
    Date Cleared
    2010-09-17

    (487 days)

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

    ONE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This is a hand held device intended to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
    Device Description
    The Baby Quasar consists of a collection of red and near infrared diodes [LEDs], packaged in a compact handheld device. The device has a head containing the led array, momentary switch, and indicator light.
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    K Number
    K091125
    Device Name
    CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2
    Manufacturer
    VERILUX
    Date Cleared
    2010-09-03

    (504 days)

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

    ONE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearWave Phototherapy System for Acne provides phototherapeutic blue light to treat mild to moderate inflammatory acne.
    Device Description
    The Clear Wave® Phototherapy System for Acne is a hand held light device which emits a low intensity of blue light at a wavelength of 414 ± 10 nm in the visible range of the spectrum. The head is programmed with a timed treatment cycle. The light modules are contained in the changeable head of a hand held device. The Clear Wave® Phototherapy System for Acne is small and light weight which allows for easy handling and mobility.
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    K Number
    K092800
    Device Name
    ANTI-WRINKLE (AGING) LIGHT, MODEL AAL
    Manufacturer
    LED INTELLECTUAL PROPERTIES, LLC
    Date Cleared
    2010-02-04

    (146 days)

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

    ONE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Anti-Wrinkle Light, model: AAL, is a handheld device intended for use in the treatment of periorbital wrinkles. The Anti-Wrinkle Light is a hand held device intended to emit energy in the visible and IR regions of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
    Device Description
    The Anti-Wrinkle Light, Model AAL is a hand-held device consisting of low intensity light emitting diodes (LED's) that emit Low and Sub- IR light for direct exposure to the skin. The device components include an LED array of 605nm, 630nm, 660nm, and 855nm wavelengths, a (non-flammable plastic) hand piece housing a printed circuit board upon which the LED's are mounted, single non-timer on/off switch with 5-ohm resistor, receiver jack in the hand piece accommodating a removable power cord and a separate AC to DC ( 9-volt ) power supply. Treatment time is recommended to be 3 minutes and is controlled by the user.
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