LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K252272
    Device Name
    ORA Method LED Gua Sha (GS-04)
    Manufacturer
    Shenzhen Kaiyan Medical Equipment Co., Ltd
    Date Cleared
    2025-10-09

    (79 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K250761,K242382,K242700
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ORA Method LED Gua Sha (Model: GS-04) is an Over-the-Counter (OTC) device indicated to emit energy in red and infrared region of the spectrum for treatment of full-face and decolletage wrinkles.

    Device Description

    The ORA Method LED Gua Sha (Model: GS-04) is a hand-held, battery-powered device used for the treatment of full-face and decolletage wrinkles by emitting LED red(630nm) and infrared(830nm) light. The device is powered by a Lithium-Ion rechargeable battery, and it has a charging cable,charging base, Goggles,storage bag and instruction manual.

    The device have two functions:

    A) Red and infrared irradiation function:The device emits energy in red and infrared region of the spectrum to reduce wrinkles on the face and decolletage;

    B) Vibration and Gua Sha function. The device generates micro-vibration at a frequency of 200 Hz via its built-in micro motor. When used in conjunction with Gua Sha operation, it provides a soothing massage to the skin intended for relaxing the skin.

    The recommended treatment time is 10 minutes per area. If you need to continue treatment, simply turn on the device again.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1