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510(k) Data Aggregation

    K Number
    K252053
    Date Cleared
    2025-10-27

    (118 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    VITA Multi-Function Head Brush is an Over-The-Counter (OTC) device.

    Head Mode: The device is indicated to promote hair growth in male with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V and females with androgenic aplopecia who have Ludwig-Savin Classification of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.

    Face Mode:
    LED therapy function: The device is indicated for the treatment of full face wrinkles and/or mild to moderate inflammatory acne.

    Device Description

    The VITA Multi-Function Head Brush is a hand-held device. It consists of a host, a removable treatment head, and a charging cable. The host has a button, indicator lights, and the device's power-on/off, treatment mode switch can be achieved by pressing the button. The removable treatment head has lights row, stainless steel bristles and liquid reservoir (applicable for model TB-2443F/ TB-2442AF), of which the liquid reservoir is used for the hair care after treatment.

    The LEDs and low-level lasers in the removable treatment head emit light on the treatment area. In addition, the device is also equipped with a built-in micro motor to generates micro-vibration to relax the facial skin. The device has a head mode and face mode, and the device will automatically shut down after each mode completes treatment within 10 minutes. The device is powered by a built-in rechargeable lithium battery.

    AI/ML Overview

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