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

    O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS

    K Number: K954124 · Decision Mar 19, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    117
    Applicant Total
    2
    Review Days
    200

    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
    O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS
    K Number
    K954124
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Optical Polymer Research, Inc.
    Date Received
    September 1, 1995
    Decision Date
    March 19, 1996
    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 Optical Polymer Research, Inc.

    K Number Device Name
    K002703 O-PERM 30