BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Strata Skin Sciences, inc.

    Reg #: 2031934 · FEI: 3002942014 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    Strata Skin Sciences, inc.
    Registration Number
    2031934
    FEI Number
    3002942014
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2375 Camino Vida Roble, Suite B
    City
    Carlsbad
    State
    CA
    ZIP
    92011
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193478

    Owner / Operator

    Firm Name
    STRATA Skin Sciences, INC.
    Operator Number
    9036949
    Address
    2375 Camino Vida Roble, Suite B
    City
    Carlsbad
    State
    CA
    Postal Code
    92011
    Country
    US
    Correspondent
    Charles Mierkiewicz

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF

    Proprietary Names

    XTRAC AL10000 Momentum TheraClear TheraClearX XTRAC XTRAC Excimer Laser Phototherapy System XTRAC Excimer Laser Phototherapy System Model No. AL10000 XTRAC XL, MODEL AL8000 VTRAC EXCIMER LAMP SYSTEM Theraclear

    Establishment Types

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