BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SOLAS MEDICAL LLC

    Reg #: 3037874486 · FEI: 3037874486 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    SOLAS MEDICAL LLC
    Registration Number
    3037874486
    FEI Number
    3037874486
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3355 Blackburn St Unit 5402
    City
    Dallas
    State
    TX
    ZIP
    75204
    Country
    US

    Regulatory Submissions

    510(k) Number
    K203491

    Owner / Operator

    Firm Name
    Solas Medical LLC
    Operator Number
    10093192
    Address
    3355 Blackburn St Unit 5402
    City
    Dallas
    State
    TX
    Postal Code
    75204
    Country
    US
    Correspondent
    Ciaran T Smythe

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    Light Based Over-The-Counter Hair Removal OHT
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG

    Proprietary Names

    Solas OmniPico Solas 10600 FX Solas IPL Solas IPL Pro Solas QuadraDiode Solas SonoSkin Solas CO2 Dragan

    Establishment Types

    Repack or Relabel Medical Device