BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Photonica USA LLC

    Reg #: 3010053203 · FEI: 3010053203 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    7
    Establishment Types
    4
    Classifications
    3

    Registration Details

    Registration Name
    Photonica USA LLC
    Registration Number
    3010053203
    FEI Number
    3010053203
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1980 N Atlantic Ave Ste 1008
    City
    Cocoa Beach
    State
    FL
    ZIP
    32931
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202361

    Owner / Operator

    Firm Name
    Photonica USA LLC
    Operator Number
    10088608
    Address
    1980 N Atlantic Ave, 1030
    City
    Cocoa Beach
    State
    FL
    Postal Code
    32931
    Country
    US

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Fat Reducing Low Level Laser OLI
    Lamp, Infrared, Therapeutic Heating ILY

    Proprietary Names

    UltraSlim Digital UltraSmooth Digital Alesis OSA1 UltraSlim UltraSmooth Vevazz ELITE UltraSlim Digital / UltraSlim Professional

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility