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

    MENICON Z RIGID GAS PERMEABLE CONTACT LENS

    K Number: K081443 · Decision Sep 23, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    117
    Applicant Total
    17
    Review Days
    124

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MENICON Z RIGID GAS PERMEABLE CONTACT LENS
    K Number
    K081443
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Menicon Co, Ltd.
    Date Received
    May 22, 2008
    Decision Date
    September 23, 2008
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HQD), ordered by most recent decision date.

    GPA (hexafocon A) Rigid Gas Permeable Contact Lenses

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BostonSight® Specialty Lenses

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    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

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all

    Other Clearances by Menicon Co, Ltd.

    K Number Device Name
    K193399 Miru 1day UpSide (midafilcon A)
    K191872 Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution
    K180819 One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens
    K180004 Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens
    K173136 Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
    K151768 Menicon Saline Rinse Solution
    K130805 MENICON UNIQUE PH MULTI-PURPOSE SOLUTION
    K122273 MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS
    K102895 ONE DAY FLAT PACK
    K103561 MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
    Search all 17 clearances from Menicon Co, Ltd. →