BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SCITON, INC.

    Reg #: 2953696 · FEI: 3001415984 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    6
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    SCITON, INC.
    Registration Number
    2953696
    FEI Number
    3001415984
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    925 COMMERCIAL STREET
    City
    Palo Alto
    State
    CA
    ZIP
    94303
    Country
    US

    Regulatory Submissions

    510(k) Number
    K070388

    Owner / Operator

    Firm Name
    SCITON, INC.
    Operator Number
    9033367
    Address
    925 COMMERCIAL ST., --
    City
    Palo Alto
    State
    CA
    Postal Code
    94303
    Country
    US

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Laser Assisted Lipolysis ORK
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG

    Proprietary Names

    Profile Joule JOULE diVa Laser Device mJoule BBLs JOULE Multi-Platform System

    Establishment Types

    Remanufacture Medical Device Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198