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

    MENICON UNIQUE PH MULTI-PURPOSE SOLUTION

    K Number: K130805 · Decision Jul 3, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    32
    Applicant Total
    17
    Review Days
    100

    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 UNIQUE PH MULTI-PURPOSE SOLUTION
    K Number
    K130805
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5918
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Menicon Co, Ltd.
    Date Received
    March 25, 2013
    Decision Date
    July 3, 2013
    Product Code
    MRC
    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
    MRC Products, Contact Lens Care, Rigid Gas Permeable

    Similar 510(k) Clearances

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

    cleadew GP hydra one

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Boston One Step Liquid Enzymatic Cleaner

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VibrantVue Scleral Saline

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MaxiTears Contacts PF

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Nutrifill

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner

    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
    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
    K082855 MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
    Search all 17 clearances from Menicon Co, Ltd. →