BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Theraclear

    Reg #: 2031934 · FEI: 3002942014 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Strata Skin Sciences, inc.
    Registration Number
    2031934
    FEI Number
    3002942014
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2375 Camino Vida Roble, Suite B
    City
    Carlsbad
    State
    CA
    ZIP
    92011
    Country
    US

    Regulatory Submissions

    510(k) Number
    K101415

    Owner / Operator

    Firm Name
    STRATA Skin Sciences, INC.
    Operator Number
    9036949
    Address
    5 Walnut Grove Drive, Suite 140
    City
    Horsham
    State
    PA
    Postal Code
    19044
    Country
    US
    Correspondent
    Charles Mierkiewicz

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Theraclear

    Establishment Types

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