BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACUITY POLYMERS INC.

    Reg #: 3012228452 · FEI: 3012228452 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    17
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    ACUITY POLYMERS INC.
    Registration Number
    3012228452
    FEI Number
    3012228452
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1667 Lake Ave, Buiding 59, Suite 303
    City
    Rochester
    State
    NY
    ZIP
    14615
    Country
    US

    Regulatory Submissions

    510(k) Number
    K033599
    PMA Number
    P880024

    Owner / Operator

    Firm Name
    Acuity Polymers, Inc.
    Operator Number
    10051193
    Address
    1667 Lake Avenue, Building 59, Suite 303
    City
    Rochester
    State
    NY
    Postal Code
    14615
    Country
    US

    Products

    Device Name Product Code
    Lens, Contact (Other Material) - Daily HQD
    Lenses, Soft Contact, Daily Wear LPL
    Lens, Contact (Polymethylmethacrylate) HPX

    Proprietary Names

    Onsi-56 Acuity 200™ Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens Acuity 200 (fluoroxyfocon A) Irregular Cornea indications Lagado LSH Acuity 58 (enflufocon B) Acuity 18 (enflufocon A) Acuity 100 (hexafocon A) Tyro-97 Acuity 85 (oprifocon A) PMMA Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Acuity 200 (fluoroxyfocon A) and Acuity 100 (hexafocon A) GP Contact Lens; with and without Tangible Hydra-PEG Acuity 200 TYRO-97 (hofocon A) and ONSI 56 (onsifocon A) Irregular Cornea indications SA-18, SA-32 FSA 18, FSA 30, FSA 60, HS-50 Flosi

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility