BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Atlantis

    Reg #: 1065845 · FEI: 3003040707 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    51
    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
    K183167

    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
    Lens, Contact (Other Material) - Daily HQD

    Proprietary Names

    Atlantis Pinnacle Atlantis FT Spherical Pinnacle IC Titan LD Starlens Apex Atlantis TPC Atlantis 3D X-Cel Thin Atlantis MF Pinnacle LD Atlantis LD Wave Aspheric Periphery Infinity GP Solution Bifocal Bitoric Proplus Bifocal Envision Reverse Geometry QuadraCurve ProLook Essential Solutions Flex 3 Visions Read Rite Bifocal X-Cel Cone CV-4 Limbal ContinuVu Plus SCone Front Toric Visions Custom Bi-Toric Summit Post Lasik Jupiter Plus ePerimeter Summit PostGraft American Standard Continu Vu eJupiter Arc-Seg MegaThin Aspheric EasyFocus Plus MVP EZEyes TriCurve

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)