BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens

    K Number: K162005 · Decision Dec 8, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    117
    Applicant Total
    11
    Review Days
    141

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    Basic Information

    Device Name
    Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
    K Number
    K162005
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acuity Polymers, Inc.
    Date Received
    July 20, 2016
    Decision Date
    December 8, 2016
    Product Code
    HQD
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HQD Lens, Contact (Other Material) - Daily

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    Other Clearances by Acuity Polymers, Inc.

    K Number Device Name
    K242393 Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses
    K240618 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens
    K230965 Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens
    K213538 Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
    K203571 Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
    K201194 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
    K180988 Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
    K170001 Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens
    K170007 Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens
    K163254 Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens
    Search all 11 clearances from Acuity Polymers, Inc. →