BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ASPEN LASER SYSTEMS, LLC

    Reg #: 3011387816 · FEI: 3011387816 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    ASPEN LASER SYSTEMS, LLC
    Registration Number
    3011387816
    FEI Number
    3011387816
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    175 N 1800 W Ste 108
    City
    Lindon
    State
    UT
    ZIP
    84042
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142078

    Owner / Operator

    Firm Name
    Aspen Laser Systems, LLC
    Operator Number
    10048301
    Address
    175 North 1800 West, Suite 108
    City
    Lindon
    State
    UT
    Postal Code
    84042
    Country
    US
    Correspondent
    Charles Vorwaller

    Products

    Device Name Product Code
    Lamp, Infrared, Therapeutic Heating ILY

    Proprietary Names

    ASCENT Medical Therapy Laser Series SUMMIT Medical Therapy Laser Series APEX Medical Therapy Laser Series PINNACLE Medical Therapy Laser Series APEX - 6 Wavelength, 58 Watt Medical Laser System ALPINE Medical Therapy Laser Series

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198