BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    LENSERT CONTACT LENS CLEANING & INSERT

    K Number: K830738 · Decision Jun 10, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    94

    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
    LENSERT CONTACT LENS CLEANING & INSERT
    K Number
    K830738
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5420
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Jermyn Specialties of California
    Date Received
    March 8, 1983
    Decision Date
    June 10, 1983
    Product Code
    KYE
    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
    KYE Inserter/Remover Contact Lens

    Similar 510(k) Clearances

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

    SOFT CONTACT LENS REMOVER

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    HARD CONTACT LENS REMOVER. ITEM #289

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    CONTACT LENS TWEEZERS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SUMMIT OPTICS CONTACT LENS REMOVER

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MARLIN SOFT LENS TWEEZER

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MARLIN SOFT LENS HANDLER

    FDA 510(k)
    FDA Class 1 ·Ophthalmic
    View all

    Other Clearances by Jermyn Specialties of California

    K Number Device Name
    K830737 JERMYN OCCLUDERS KIT