BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EVOSKIN LLC

    Reg #: 3021334828 · FEI: 3021334828 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    4

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    Registration Details

    Registration Name
    EVOSKIN LLC
    Registration Number
    3021334828
    FEI Number
    3021334828
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    6 Lincoln Knoll Ln Ste 100A
    City
    Burlington
    State
    MA
    ZIP
    01803
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212790

    Owner / Operator

    Firm Name
    Evoskin LLC
    Operator Number
    10084093
    Address
    6 Lincoln Knoll Ln Ste 100A
    City
    Burlington
    State
    MA
    Postal Code
    01803
    Country
    US
    Correspondent
    Mike Berisha

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF
    Brush, Dermabrasion, Manual GED
    Platelet And Plasma Separator For Bone Graft Handling ORG

    Proprietary Names

    XLASE PLUS FUSE X ENDORET

    Establishment Types

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