BEUDAMED
    FDA Registration Active 🇺🇸 United States

    X-CEL SPECIALTY CONTACTS

    Reg #: 1065845 · FEI: 3003040707 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    112
    Establishment Types
    3
    Classifications
    6

    Registration Details

    Registration Name
    X-CEL SPECIALTY CONTACTS
    Registration Number
    1065845
    FEI Number
    3003040707
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2775 Premiere Pkwy Ste 600
    City
    DULUTH
    State
    GA
    ZIP
    30097
    Country
    US

    Regulatory Submissions

    510(k) Number
    K950294
    PMA Number
    P830012

    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
    Lenses, Soft Contact, Daily Wear LPL
    Lens, Contact, Orthokeratology, Overnight NUU
    Lens, Contact (Orthokeratology) MUW
    Lens, Contact (Polymethylmethacrylate) HPX
    Lens, Contact (Rigid Gas Permeable), Extended Wear MWL

    Proprietary Names

    Flex 3 Bi-Toric SCone MegaThin Bi-Toric Summit ContinuVu Front Toric Limbal American Standard Reverse Geo ContinuVu Plus PostGraft Aspheric TriCurve MVP Flexlens Aphakic Flexlens Sphere Flexlens Piggyback Flexlens Prism Sphere Flexlens Tricurve Keratoconus Flexlens PRS Flexlens Keratoconus Flexlens Adult Aphakic Flexlens Large Diameter Flexlens Large Diameter Thick Edge Westcon Horizon Adult Aphakic Flexlens Toric Westcon Horizon Aphakic Rose K2 Rose K2 PG Rose K2 IC Atlantis 3D Atlantis MF Titan LD Atlantis Spherical Apex Atlantis LD Pinnacle LD Starlens Pinnacle Atlantis TPC Atlantis FT Pinnacle IC Reverse Geometry Proplus Bifocal EZEyes X-Cel Cone Wave QuadraCurve Summit Solution Bifocal EasyFocus Plus Continu Vu eJupiter Visions Post Lasik Aspheric Periphery eJupiter Plus Infinity GP Visions Custom Bitoric ePerimeter Read Rite Bifocal Arc-Seg CV-4 ProLook Rose K2 NC Rose K2 XL Oblate Rose K2 XL Rose K RG5 Overnight Ortho-K Lens GOV Overnight Ortho-K Lens S-10 Ideal Cone Apogee Ful-Vue Westcon Horizon Prism Sphere Westcon Westhin Toric Westcon Horizon Toric Westcon Horizon Progressive Westcon Horizon Bi-Con Westcon Horizon Bi-Con Toric Flexlens Multifocal Westcon Horizon Progressive Toric Flexlens ARC Westcon Horizon Sphere Reverse Geometry Sphere Flexlens Idealsoft Flexlens Idealsoft PS Perimeter Semi-Scleral Jupiter Westcon Horizon Large Diameter Horizon/Westhin 55-G Rev Geo TPC Rev Geo Sphere Rev Geo Front Toric ProPlus Bifocal Jupiter Plus Inside Toric X-Cel Thin REMLens Envision Essential Solutions Flexlens Horizon 55 Bi-Con Horizon/Westhin 38 softblu (Polymacon) soft (Spherical and Toric) XRP Toric Trial XRP Toric Horizon 38 clear and tinted Orison

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Sterilize Medical Device for Another Party (Contract Sterilizer)