LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K242859
    Device Name
    VEGA
    Manufacturer
    Ibramed Equipamentos Médicos
    Date Cleared
    2025-09-19

    (364 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K222862,K222064
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Vega Triple Wave Applicator (755nm/ 810nm/ 1064nm)
    Indications for use of the Triple Wave Applicator, Includes:
    The Super Hair Removal (SHR) mode is intended for the temporary reduction of hair.

    Vega 810nm Applicator:
    Indications for use of the 810nm Applicator, Includes:
    The Hair Removal (HR) and Super Hair Removal (SHR) modes are intended for the permanent reduction of hair regrowth, defined as a stable and long-term reduction in the number of hairs that regrow, measured at 6, 9, and 12 months after completing a treatment regimen. It is suitable for use on all skin types (Fitzpatrick I-VI), including tanned skin, when using the HR and SHR mode.

    Device Description

    VEGA is a high-power laser therapy device with electromagnetic emission in the infrared spectrum, designed for long-lasting hair removal on all skin types. Laser energy can be transferred to the treatment area via an 810nm or triple wave (755, 810, 1065nm) handpiece.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1