BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Gemini 810+980 Diode Laser

    Reg #: 1000548922 · FEI: 1000548922 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ALL QUALITY & SERVICES, INC.
    Registration Number
    1000548922
    FEI Number
    1000548922
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    47817 Fremont Blvd
    City
    Fremont
    State
    CA
    ZIP
    94538
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192617

    Owner / Operator

    Firm Name
    All Quality & Services, Inc.
    Operator Number
    10046808
    Address
    2010 Merritt Dr
    City
    Garland
    State
    TX
    Postal Code
    75041
    Country
    US
    Correspondent
    Amir Nosrati

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Lamp, Infrared, Therapeutic Heating ILY

    Proprietary Names

    Gemini 810+980 Diode Laser

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)