BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece

    K Number: K170626 · Decision May 31, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    8
    Review Days
    90

    Basic Information

    Device Name
    Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece
    K Number
    K170626
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alma Lasers Inc.
    Date Received
    March 2, 2017
    Decision Date
    May 31, 2017
    Product Code
    GEX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEX Powered Laser Surgical Instrument

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GEX), ordered by most recent decision date.

    AviClear Laser System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Pastelle

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SurgiLight 1470 Diode Laser System (Model:Halo)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AuroLase® System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Diode laser device (RF3120-BI)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Alma Lasers Inc.

    K Number Device Name
    K230371 The Alma Soprano Titanium
    K222064 The Alma Soprano Titanium
    K201520 The Alma Opus System, Colibri Applicator and Tips
    K181298 Harmony XL Multi-Application Platform
    K172193 Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules
    K171242 Alma LipoFlow System
    K160075 Accent XL