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510(k) Data Aggregation

    K Number
    K242441
    Device Name
    Revian Lyte (10011)
    Manufacturer
    Date Cleared
    2024-09-13

    (28 days)

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

    Revian, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Revian Lyte device is indicated to treat Androgenetic Alopecia and to promote hair growth in males who have Norwood-Hamilton Classifications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale |-1 to |-4, || -1, ||-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
    Device Description
    The Revian Lyte device is a model (10011) within the Revian Red (10001) family of devices. Revian Lyte is an over the counter (OTC) home-use, non-invasive, hands-free device indicated to treat androgenetic alopecia in both men and promote hair growth using Modulated Light Therapy (MLT) and a 10-minute daily treatment. The Revian Lyte cap is designed to treat the scalp and temple areas. The device is a non-sterile, single user, multi-use therapy device. Revian Lyte is a system comprised of a wearable soft textile cap and protective inner liner together which encase driver electronics, a rechargeable battery, and an integrated light emitting diode (LED) array on a flexible Printed Circuit Board (PCB). The protective inner liner, a plastic lenticular lens, covers the treatment LED array and electronics and is in direct contact with the patient's scalp. The lenticular lens disperses LED light over the treatment area. The Revian Lyte device emits non-coherent visible red light at two target peak wavelengths (620nm and 660nm). When the Lyte cap is placed onto the head, a capacitive touch sensor (proximity sensor) embedded in the flexible printed circuit board senses the presence of the scalp and turns on the cap. Removable and adjustable foam headliners ensure that the cap fits snugly on the scalp and ensure that the proximity sensor is in close contact with the scalp. A series of blinking indicator LEDs and audible tones provide information to the user such as the status of battery charge, treatment status, etc. At the end of treatment, a series of 3 audible beeps signal that the treatment has finished and the device automatically shuts off. Lyte is controlled via embedded firmware. The battery is recharged between uses using an AC power adapter and a USB charging cable. The Revian Lyte includes: (1) A treatment cap with integrated electronics, (2) Accessory Kit containing the USB Charging Cable with AC Power Adaptor and set of Adjustable Headliners, (3) Clear Charging Base used to rest the Cap when not in use and to rest the Cap to charge between treatments and, (4) Instructions for Use (IFU).
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