BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    ALMA LASERS LTD.

    Reg #: 3004167969 · FEI: 3004167969 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    47
    Establishment Types
    3
    Classifications
    18

    Registration Details

    Registration Name
    ALMA LASERS LTD.
    Registration Number
    3004167969
    FEI Number
    3004167969
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    18 Haharash Street, NORTH INDUSTRIAL PARK
    City
    CAESAREA Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K230371

    Owner / Operator

    Firm Name
    ALMA LASERS LTD.
    Operator Number
    9055441
    Address
    485 half day rd
    City
    Buffalo Grove
    State
    IL
    Postal Code
    60089
    Country
    US
    Correspondent
    Avi - Farbstein

    Products

    Device Name Product Code
    Medical Device Data System OUG
    Lamp, Infrared, Therapeutic Heating ILY
    Powered Laser Surgical Instrument GEX
    Light, Ultraviolet, Dermatological FTC
    Laser, Surgical, Gynecologic HHR
    Laser For Gastro-Urology Use LNK
    Light Based Over The Counter Wrinkle Reduction OHS
    Lipoaspirate Washing System For Aesthetic Body Contouring QKL
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    System, Suction, Lipoplasty MUU
    Massager, Therapeutic, Electric ISA
    Massager, Vacuum, Light Induced Heating NUV
    Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat IMI
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF
    Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis PDZ
    Over-The-Counter Powered Light Based Laser For Acne OLP
    Laser, Comb, Hair OAP

    Proprietary Names

    The Alma Soprano Titanium Soprano ICE Platinum HarmonyXL MultiApplication Platform; Harmony XL Pro; Beauty Rejuve LMNT One Alma Harmony Alma Q Alma LipoFlow System Arion Modified Family of Lovely Systems; LOVELY II (HARMONY); LOVEY I (ARIA); Harmony Elite Pixel RF Tips; Opus System; Beauty Reform 308 Dermatological Excimer System Lipolife Family; Alma LipoFlow System vShape Ultra; Accent Prime Alma Diode Tabletop Laser Alma Veil Alma Hybrid Laser System Sinon The Alma Opus System, Colibri Applicator and Tips Alma DUO Liposense/BeautiFirm Accent UniForm Massager Module Soprano XL Multi-Application Platform; Beauty Remove Alma Family of Thermo XEL Handpieces LOVELY II (HARMONY); Lovely System Models; LOVELY I (ARIA) EXELO2, MODEL 4010 Beauty Reform; Accent Elite Harmony XL Multi-Application Platform FemiLift / Pixel CO2 Laser System Alma Pixel Modified Harmony 1064nm Nd:YAG Modules The Alma Hybrid Laser System Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece VorFat System / Cellfie Mydon C LMNT 02 Alex 755 Harmony XL Module Alma TED Family of Multi-application systems Soprano XL/XLi Idas Alma TED+ System The Alma Diode Tabletop Laser; BeautiFill; Alma Life 980; Alma Life 810; Alma Life 1470 Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories Harmony Lite Soprano ICE Alma Harmony Next Generation Soprano XL SHR Mode; Soprano Lite SkinFinity; Family of ACCENT RF Systems Accent XL

    Establishment Types

    Manufacture Medical Device Foreign Private Label Distributor Complaint File Establishment per 21 CFR 820.198