BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    BIOPTRON MedAll

    Reg #: 3003775404 · FEI: 3003775404 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BIOPTRON AG
    Registration Number
    3003775404
    FEI Number
    3003775404
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SIHLEGGSTRASSE 23, --
    City
    WOLLERAU Schwyz
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K032216

    Owner / Operator

    Firm Name
    BIOPTRON AG
    Operator Number
    9052406
    Address
    SIHLEGGSTRASSE 23, --
    City
    WOLLERAU
    State
    CH-NOTA
    Postal Code
    CH-8832
    Country
    CH

    US Agent

    Business Name
    REGULATORY INSIGHT, INC.
    Contact Name
    Kevin Walls
    Address
    33 Golden Eagle Lane, --
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy NHN

    Proprietary Names

    BIOPTRON MedAll BIOPTRON 2 (B2) Light Therapy System BIOPTRON Pro (BPro) Light Therapy System BIOPTRON PRO 1 (BPro1) Light Therapy System BIOPTRON Compact III (BCIII) Light Therapy System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device