BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Flexlens Aphakic

    Reg #: 1065845 · FEI: 3003040707 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    X-CEL SPECIALTY CONTACTS
    Registration Number
    1065845
    FEI Number
    3003040707
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2775 Premiere Pkwy Ste 600
    City
    DULUTH
    State
    GA
    ZIP
    30097
    Country
    US

    Regulatory Submissions

    510(k) Number
    K100443

    Owner / Operator

    Firm Name
    Walman Optical
    Operator Number
    2125182
    Address
    2775 Premiere Parkway Ste 600
    City
    Duluth
    State
    GA
    Postal Code
    30097
    Country
    US
    Correspondent
    Hue N Tang

    Products

    Device Name Product Code
    Lenses, Soft Contact, Daily Wear LPL

    Proprietary Names

    Flexlens Aphakic Flexlens ARC Westcon Horizon Bi-Con Westcon Horizon Progressive Toric Flexlens Large Diameter Flexlens PRS Flexlens Prism Sphere Flexlens Tricurve Keratoconus Flexlens Toric Westcon Westhin Toric Flexlens Multifocal Westcon Horizon Toric Westcon Horizon Sphere Westcon Horizon Bi-Con Toric Westcon Horizon Progressive Flexlens Keratoconus Westcon Horizon Prism Sphere Flexlens Piggyback Flexlens Sphere Flexlens Adult Aphakic Westcon Horizon Adult Aphakic Westcon Horizon Aphakic

    Establishment Types

    Manufacture Medical Device