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510(k) Data Aggregation

    K Number
    K151336
    Device Name
    LightStim Professional 2-Panel Light
    Manufacturer
    LED INTELLECTUAL PROPERTIES, LLC
    Date Cleared
    2015-10-23

    (157 days)

    Product Code
    OHS, OLP
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    LED INTELLECTUAL PROPERTIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LightStim Professional System #3A panel is intended for the treatment of full-face wrinkles. The LightStim Professional System #3B panel is intended for the treatment of mild to moderate acne. The LightStim Professional System #4 panel is intended for the treatment of mild to moderate acne.
    Device Description
    The LightStim Professional 2-Panel Light System is a portable device that has two (2) separate interchangeable 2-panel treatment heads, each containing 1.130 LEDs. Each treatment heads is attached to a fully retractable and articulating arm with a 42" reach. Either one of these arms can be attached to the rolling stand for use. There is an on/off switch, and an AC to DC power supply. The LightStim 2-Panel Light System is intended to be operated only by a person who has been personally trained by Company personnel. Each device includes a detailed Instruction Manual and includes one-on-one training and instruction by Company training staff. That training includes a thorough review of the Instruction Manual for the device and actual one-on-one training on the operation of the device with the end user.
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    K Number
    K151333
    Device Name
    LightStim for Pain LED Belt
    Manufacturer
    LED INTELLECTUAL PROPERTIES, LLC
    Date Cleared
    2015-08-21

    (94 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    LED INTELLECTUAL PROPERTIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LightStim for Pain LED Belt is an Over-The-Counter device intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.
    Device Description
    The LightStim for Pain LED Belt is a portable device that has between one and four separate LED pods, each of which has 52 LEDs and are attached to a elastic belt that stretches to encircle different sizes from as small as an ankle to as large as the torso, and attaches to itself with Velcro. Each pod has an LED array of 630nm, 865nm, and 940nm. The device is powered by a separate AC to DC 12-volt power supply and has an on/off switch, with a timer that shuts the device off automatically after 30 minutes of operation. Recommended treatment time is 5 to 30 minutes.
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    K Number
    K150098
    Device Name
    LightStim Professional 2-Panel Light
    Manufacturer
    LED INTELLECTUAL PROPERTIES, LLC
    Date Cleared
    2015-04-09

    (79 days)

    Product Code
    OHS, ILY
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    LED INTELLECTUAL PROPERTIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LightStim Professional 2-Panel Light System has two (2) interchangeable 2-Panel LED Systems, each mounted on a hands-free, fully articulating arms: System #1- emitting energy in the visible and IR spectrums intended for use in the treatment of full-face wrinkles. System #2 - emitting energy in the visible and IR spectrum intended to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.
    Device Description
    The LightStim Professional 2-Panel Light System is a portable device that has two (2) separate interchangeable 2-panel treatment heads, each containing 1,130 LEDs. Each treatment heads is attached to a fully retractable and articulating arm with a 42″ reach. Either one of these arms can be attached to the rolling stand for use. There is an on/off switch, and an AC to DC power supply. The LightStim 2-Panel Light System is intended to be operated only by a person who has been personally trained by Company personnel. Each device includes a detailed Instruction Manual and includes one-on-one training and instruction by Company training staff. That training includes a thorough review of the Instruction Manual for the device and actual one-on-one training on the operation of the device with the end user.
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    K Number
    K142246
    Device Name
    LightStim for Acne/ LightStim for Acne Mini
    Manufacturer
    LED INTELLECTUAL PROPERTIES, LLC
    Date Cleared
    2015-01-29

    (168 days)

    Product Code
    OLP
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    LED INTELLECTUAL PROPERTIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LightStim for Acne/LightStim for Acne Mini is an over-the-counter hand-held device intended for the use in the treatment of mild to moderate acne.
    Device Description
    LightStim for Acne / LightStim for Acne Mini, model: LS4A/LS4AM is a hand-held device consisting of low intensity light emitting diodes (LED's) that provide illumination which comes in contact with the skin. The device components include LED's of 415nm and 630nm, a hand piece, a printed circuit board, an on/off switch, a resistor, a receiver jack in the hand piece to plug a power supply into and a separate AC to DC (9 volt) power supply. Treatment time is recommended to be three to four minutes and is controlled by the user.
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    K Number
    K131461
    Device Name
    LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI
    Manufacturer
    LED INTELLECTUAL PROPERTIES, LLC
    Date Cleared
    2014-01-06

    (231 days)

    Product Code
    OLP
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    LED INTELLECTUAL PROPERTIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LightStim for Acne Mini is an over-the-counter hand-held device intended for the use in the treatment of mild to moderate acne.
    Device Description
    LightStim for Acne Mini, model: LS4AM is a hand-held device consisting of low intensity light emitting diodes (LED's) that provide illumination which comes in contact with the skin. The device components include LED's of 415nm, a hand piece, a printed circuit board, an on/off switch, a resistor, a receiver jack in the hand piece to plug a power supply into and a separate AC to DC (9 volt) power supply. Treatment time is recommended to be three to four minutes and is controlled by the user.
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    K Number
    K120775
    Device Name
    LIGHT FOR WRINKLES
    Manufacturer
    LED INTELLECTUAL PROPERTIES, LLC
    Date Cleared
    2012-06-04

    (82 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    LED INTELLECTUAL PROPERTIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LightStim for Wrinkles is an over-the-counter hand-held device intended for the use in the treatment of full-face wrinkles
    Device Description
    The LightStim for Wrinkles is a hand-held device with a power output of 65mW/cm2, consisting of light emitting diodes (LED's) that emit Low and Sub IR light for direct exposure to the skin. The components include an LED array of 605nm, 630nm, 660nm, and 855nm wavelength, 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 a 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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    K Number
    K101190
    Device Name
    LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC
    Manufacturer
    LED INTELLECTUAL PROPERTIES, LLC
    Date Cleared
    2010-07-01

    (64 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    LED INTELLECTUAL PROPERTIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Light for Winkles is an Over-The-Counter handheld device intended for use in the treatment of periorbital wrinkles.
    Device Description
    The Light for Wrinkles is a hand-held device with a power output of 65mW/cm2, 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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    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?
    Applicant Name (Manufacturer) :

    LED INTELLECTUAL PROPERTIES, LLC

    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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    K Number
    K083580
    Device Name
    ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301
    Manufacturer
    LED INTELLECTUAL PROPERTIES, LLC
    Date Cleared
    2009-06-22

    (201 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    LED INTELLECTUAL PROPERTIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pain Therapy Light, model: PTL, is an Over-The-Counter hand held device intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local and blood circulation, and the temporary relaxation of muscles.
    Device Description
    Pain Therapy Light Model 1301 is a hand-held device consisting of low intensity light emitting diodes (LED's) that provide infra-red light to the skin. Physical components include an LED array emitting 630, 660, 855 and 940nm respectively in a handheld "wand" configuration containing a simple "in/out" integrated chip with external, manual on/off switch, a single electronic resistor, and a removable 9 volt AC-to-DC power supply. Treatment times are as required by the user, and specified by the User's Manuals for product code ILY indications.
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