BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    BIOPTRON AG

    Reg #: 3003775404 · FEI: 3003775404 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    45
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    BIOPTRON AG
    Registration Number
    3003775404
    FEI Number
    3003775404
    Status
    Active
    Expiry Year
    2026
    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
    Sunglasses (Non-Prescription Including Photosensitive) HQY

    Proprietary Names

    BIOPTRON MedAll BIOPTRON Pro (BPro) Light Therapy System BIOPTRON Compact III (BCIII) Light Therapy System BIOPTRON 2 (B2) Light Therapy System BIOPTRON PRO 1 (BPro1) Light Therapy System THE-0101BN TESLA HYPERLIGHT EYEWEAR, MODEL 5355, BROWN THE-0102BN TESLA HYPERLIGHT EYEWEAR, MODEL 5355, BROWN, MRBU THE-0101BG TESLA HYPERLIGHT EYEWEAR, MODEL 5355, BEIGE THE-0502BN TESLA HYPERLIGHT EYEWEAR, MODEL 05, BROWN, MRBU TLW-001BL TESLA HYPERLIGHT EYEWEAR, MODEL 001, BLACK THE-0602BU TESLA HYPERLIGHT EYEWEAR, AVIATOR, BLUE THE-0101GY TESLA HYPERLIGHT EYEWEAR, MODEL 5355, SILVER THE-0102GY TESLA HYPERLIGHT EYEWEAR, MODEL 5355, SILVER, MRBU THE-0401VT TESLA HYPERLIGHT EYEWEAR, MODEL 04, VIOLET TLW-107BLU TESLA HYPERLIGHT EYEWEAR, MODEL 107, BLUE TLW-107BR TESLA HYPERLIGHT EYEWEAR, MODEL 107, BROWN THE-0201BK TESLA HYPERLIGHT EYEWEAR, MODEL 02, BLACK THE-0101OG TESLA HYPERLIGHT EYEWEAR, MODEL 5355, ORANGE THE-0402VT TESLA HYPERLIGHT EYEWEAR, MODEL 04, VIOLET, MRBU THE-0102BG TESLA HYPERLIGHT EYEWEAR, MODEL 5355, BEIGE, MRBU THE-0401TQ TESLA HYPERLIGHT EYEWEAR, MODEL 04, TURQUOISE THE-0102OG TESLA HYPERLIGHT EYEWEAR, MODEL 5355, ORANGE, MRBU THE-0401BU TESLA HYPERLIGHT EYEWEAR, MODEL 04, BLUE TLW-107YE TESLA HYPERLIGHT EYEWEAR, MODEL 107, YELLOW THE-0601RD TESLA HYPERLIGHT EYEWEAR, AVIATOR, RED TLW-001WH TESLA HYPERLIGHT EYEWEAR, MODEL 001, WHITE THE-0402BU TESLA HYPERLIGHT EYEWEAR, MODEL 04, BLUE, MRBU THE-0501BN TESLA HYPERLIGHT EYEWEAR, MODEL 05, BROWN THE-0402RD TESLA HYPERLIGHT EYEWEAR, MODEL 04, RED, MRBU TLW-001BR TESLA HYPERLIGHT EYEWEAR, MODEL 001, BROWN TLW-001YE TESLA HYPERLIGHT EYEWEAR, MODEL 001, YELLOW THE-0402TQ TESLA HYPERLIGHT EYEWEAR, MODEL 04, TURQUOISE, MRBU TLW-107BL TESLA HYPERLIGHT EYEWEAR, MODEL 107, BLACK THE-0101BU TESLA HYPERLIGHT EYEWEAR, MODEL 5355, BLUE PZFG-TYT120 TESLA HYPERLIGHT EYEWEAR, SILHOUETTE, MODEL 120 TLW-001BLU TESLA HYPERLIGHT EYEWEAR, MODEL 001, BLUE THE-0302BN TESLA HYPERLIGHT EYEWEAR, MODEL 03, BROWN THE-0401RD TESLA HYPERLIGHT EYEWEAR, MODEL 04, RED THE-0101GN TESLA HYPERLIGHT EYEWEAR, MODEL 5355, GREEN TLW-107WH TESLA HYPERLIGHT EYEWEAR, MODEL 107, WHITE THE-0201BN TESLA HYPERLIGHT EYEWEAR, MODEL 02, BROWN THE-0401BK TESLA HYPERLIGHT EYEWEAR, MODEL 04, BLACK THE-0102GN TESLA HYPERLIGHT EYEWEAR, MODEL 5355, GREEN, MRBU THE-0402BK TESLA HYPERLIGHT EYEWEAR, MODEL 04, BLACK, MRBU THE-0102BU TESLA HYPERLIGHT EYEWEAR, MODEL 5355, BLUE, MRBU

    Establishment Types

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