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

    PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS

    K Number: K130285 · Decision Apr 3, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    81
    Applicant Total
    5
    Review Days
    57

    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
    PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS
    K Number
    K130285
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Lagado Corp.
    Date Received
    February 5, 2013
    Decision Date
    April 3, 2013
    Product Code
    LRX
    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
    LRX Case, Contact Lens

    Similar 510(k) Clearances

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

    LANDR Contact LENS Case

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MINI VP1 (PL67_F); MINI VP1 (PL61_F)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Contact Lens Case, Model: A-1, B-1

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

    Other Clearances by The Lagado Corp.

    K Number Device Name
    K120756 LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE
    K102154 TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS
    K052507 TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR
    K033599 ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS