BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SPECTRA THERAPY LLC

    Reg #: 3008539245 · FEI: 3008539245 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

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    Registration Details

    Registration Name
    SPECTRA THERAPY LLC
    Registration Number
    3008539245
    FEI Number
    3008539245
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3350 Lapeer Rd
    City
    Port Huron
    State
    MI
    ZIP
    48060
    Country
    US

    Regulatory Submissions

    510(k) Number
    K080689

    Owner / Operator

    Firm Name
    Spectra Therapy LLC
    Operator Number
    10050541
    Address
    3350 Lapeer Road
    City
    Port Huron
    State
    MI
    Postal Code
    48060
    Country
    US

    Products

    Device Name Product Code
    Lamp, Infrared, Therapeutic Heating ILY

    Proprietary Names

    A1000 LASERwrap® System A100, A100N LASERwrap® System A10, A100 LASERwrap® System

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198