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510(k) Data Aggregation

    K Number
    K223482
    Device Name
    reVive Light Therapy® Wrinkle and Acne LED Device
    Manufacturer
    LED Technologies, Inc.
    Date Cleared
    2022-12-21

    (33 days)

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

    LED Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The reVive Light Therapy® Wrinkle and Acne LED Device is intended for treatment of wrinkles and mild to moderate inflammatory acne.
    Device Description
    The reVive Light Therapy® Wrinkle and Acne LED 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, as defined in 21 CFR § 878.4810. The reVive Light Therapy® Wrinkle and Acne LED Device components include the device containing the LED module. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components.
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    K Number
    K221430
    Device Name
    reVive Light Therapy LED Cleansing System
    Manufacturer
    LED Technologies, Inc.
    Date Cleared
    2022-07-27

    (71 days)

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

    LED Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The reVive Light Therapy LED Cleansing System is intended for treatment of wrinkles and mild to moderate inflammatory acne.
    Device Description
    The reVive Light Therapy® LED Cleansing System 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, as defined in 21 CFR § 878.4810. In addition to the LED light therapy treatment function, reVive Light Therapy® LED Cleansing System has a separate function for cleansing. The system includes two cleansing brush-heads, constructed of TPE material. The reVive Light Therapy® LED Cleansing System components include the device containing the LED module, USB power cord, and power adapter. The unit 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 is sold as Over the Counter (OTC).
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    K Number
    K210968
    Device Name
    reVive Light Therapy Essentials
    Manufacturer
    LED Technologies, Inc.
    Date Cleared
    2021-12-21

    (265 days)

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

    LED Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The reVive Light Therapy® Essentials is an Over the Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
    Device Description
    The reVive Light Therapy® Essentials is an over-the counter light emitting diode (LED) device, that emits energy for use in dermatology for the treatment of mild to moderate inflammatory acne. The device uses two types of LEDs: 630nm red and 415nm blue. The reVive Light Therapy® Essentials components include the device containing the LED module. There are no user settings or adjustments required. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components.
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    K Number
    K210965
    Device Name
    reVive Light Therapy Essentials
    Manufacturer
    LED Technologies, Inc.
    Date Cleared
    2021-12-15

    (259 days)

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

    LED Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The reVive Light Therapy® Essentials is an Over the Counter (OTC) device intended for treatment of writkles.
    Device Description
    The reVive Light Therapy® Essentials is an over-the counter light emitting diode (LED) device, that emits energy for use in dermatology for the treatment of wrinkles. The device uses four types of LEDs: 605nm amber, 630nm red, 660nm red, and 880nm infrared. The reVive Light Therapy® Essentials components include the device containing the LED module. There are no user settings or adjustments required. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components.
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    K Number
    K183247
    Device Name
    dpl Faceware
    Manufacturer
    LED Technologies, Inc.
    Date Cleared
    2019-03-14

    (113 days)

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

    LED Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The dpl® Faceware is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.
    Device Description
    The dpl® Faceware 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. The device uses five types of LEDs: 605nm amber, 630nm red, 880nm infrared, and 415 blue. The dpl® Faceware components include the device containing the LED module, USB power cord, and power adapter. The treatment time is controlled by the user. There are no user settings or adjustments required. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components.
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    K Number
    K183118
    Device Name
    dpl SpotLite
    Manufacturer
    LED Technologies, Inc.
    Date Cleared
    2019-02-07

    (90 days)

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

    LED Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The dpl® SpotLite is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
    Device Description
    The dpl® SpotLite is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of mild to moderate inflammatory acne. The device uses two types of LEDs, 630nm red and 415nm blue. The treatment time is controlled by the user. There are no user settings or adjustments required. The dpl® SpotLite components include the unit containing the LED module. The unit 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 is sold as Over the Counter (OTC).
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    K Number
    K180447
    Device Name
    reVive Light Therapy LED Cleansing System
    Manufacturer
    LED Technologies, Inc.
    Date Cleared
    2018-06-04

    (104 days)

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

    LED Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    reVive Light Therapy® LED Cleansing System is an Over-the-Counter (OTC) LED device intended for use in treating mild to moderate inflammatory acne.
    Device Description
    The reVive Light Therapy® LED Cleansing system is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of mild to moderate inflammatory acne. The device uses two types of LEDs: 630nm red and 415nm blue. The treatment time is controlled by the user. There are no user settings or adjustments required. The reVive Light Therapy® LED Cleansing System components include the unit containing the LED module, USB power cord, and power adapter. The unit 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 is sold as Over the Counter (OTC). It is intended for users 13 years or older.
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    K Number
    K180445
    Device Name
    reVive Light Therapy LED Ultrasonic Wrinkle System
    Manufacturer
    LED Technologies, Inc.
    Date Cleared
    2018-05-15

    (84 days)

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

    LED Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The reVive Light Therapy® LED Cleansing System is an Over-the-Counter (OTC) LED device intended for use in treating wrinkles.
    Device Description
    The reVive Light Therapy® LED Cleansing System is an over-the counter light emitting diode (LED) device, that emits energy for use in dermatology for the treatment of wrinkles. The device uses four types of LEDs: 605nm amber, 630nm red, and 880nm infrared. In addition to the LED light therapy treatment function, reVive Light Therapy® LED Cleansing System has a separate function for cleansing. The system includes two cleansing brush-heads, constructed of TPE material. The reVive Light Therapy® LED Cleansing System components include the device containing the LED module, USB power cord, and power adapter. The treatment time is controlled by the user. There are no user settings or adjustments required. The unit 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 is sold as Over the Counter (OTC).
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    K Number
    K180320
    Device Name
    dpl IIa Panel
    Manufacturer
    LED Technologies, Inc.
    Date Cleared
    2018-04-03

    (57 days)

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

    LED Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The dpl® IIa Panel is an Over-the Counter (OTC) device intended for use in treating wrinkles, and treatment of mild to moderate inflammatory acne.
    Device Description
    The dpl® IIa Panel system 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. The device uses five types of LEDs: 605nm amber, 630nm red, 660nm red, and 880nm infrared, and 415nm blue. The treatment time is controlled by the user. There are no user settings or adjustments required. The dpl® IIa Panel system components include the panel unit containing the LED module, power supply, goggles, and storage case. The unit 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 is sold as Over the Counter (OTC).
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    K Number
    K172662
    Device Name
    reVive Perioral
    Manufacturer
    LED Technologies, Inc.
    Date Cleared
    2018-01-09

    (126 days)

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

    LED Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The reVive® Perioral LED Light Therapy system is an Over-the-Counter (OTC) device intended for treatment of fine lines and wrinkles, and increase in circulation within the perioral region.
    Device Description
    The reVive® Perioral LED Light Therapy system is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for treatment fine lines and wrinkles, and increase in circulation within the perioral region. The device uses four types of LEDs: 605nm amber, 630nm red, 660nm red, and 880nm infrared. The treatment time is controlled by the user. There are no user settings or adjustments required. The reVive® Perioral LED Light Therapy system components include the device containing the LED module, USB charging cord, and a storage bag. The unit 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 is sold as Over The Counter (OTC).
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