BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hairmax LaserComb Ultima 12 Classic

    Reg #: 3006182775 · FEI: 3006182775 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    Lexington International LLC
    Registration Number
    3006182775
    FEI Number
    3006182775
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1040 HOLLAND DR
    City
    Boca Raton
    State
    FL
    ZIP
    33487
    Country
    US

    Regulatory Submissions

    510(k) Number
    K110233

    Owner / Operator

    Firm Name
    LEXINGTON INTERNATIONAL, LLC
    Operator Number
    9055586
    Address
    1040 Holland Drive, --
    City
    Boca Raton
    State
    FL
    Postal Code
    33487
    Country
    US
    Correspondent
    Jose - Robert

    Products

    Device Name Product Code
    Laser, Comb, Hair OAP

    Proprietary Names

    Hairmax LaserComb Ultima 12 Classic HairMax LaserComb Ultima 12 HairMax LaserComb Ultima 9 Hairmax LaserComb Ultima 9 Classic HairMax Professional 12 Actonis™ 18 Dual Action

    Establishment Types

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