BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACUVUE OASYS with HydraLuxe

    Reg #: 3006015326 · FEI: 3006015326 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ADVANCED CONCEPT INNOVATIONS LLC
    Registration Number
    3006015326
    FEI Number
    3006015326
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4100 S. FRONTAGE RD., Suite 104
    City
    LAKELAND
    State
    FL
    ZIP
    33815
    Country
    US

    Regulatory Submissions

    510(k) Number
    K042275

    Owner / Operator

    Firm Name
    ADVANCED CONCEPT INNOVATIONS LLC
    Operator Number
    9094662
    Address
    4100 S. FRONTAGE RD., ste 104
    City
    Lakeland
    State
    FL
    Postal Code
    33815
    Country
    US
    Correspondent
    Matthew Muller

    Products

    Device Name Product Code
    Lens, Contact, (Disposable) MVN
    Lenses, Soft Contact, Daily Wear LPL

    Proprietary Names

    ACUVUE OASYS with HydraLuxe ACUVUE OASYS for ASTIGMATISM ACUVUE OASYS ACUVUE OASYS for PRESBYOPIA

    Establishment Types

    Repack or Relabel Medical Device