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

    BAUSCH & LOMB INJECTOR SYSTEM

    K Number: K131958 · Decision Jan 9, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    62
    Applicant Total
    10
    Review Days
    196

    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
    BAUSCH & LOMB INJECTOR SYSTEM
    K Number
    K131958
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4300
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bausch & Lomb
    Date Received
    June 27, 2013
    Decision Date
    January 9, 2014
    Product Code
    MSS
    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
    MSS Folders And Injectors, Intraocular Lens (Iol)

    Similar 510(k) Clearances

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

    RxSight® Insertion Device

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    ACCUJECT Injector Set 2.1-1P (LP604590)

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    EyeGility™ Inserter for Preloaded enVista IOLs

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Accuject Refra Injector AR2900

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    RxSight® Insertion Device (63002)

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    RxSight Insertion Device

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

    Other Clearances by Bausch & Lomb

    K Number Device Name
    K133486 STELLARIS PC VISION ENHANCEMENT SYSTEM
    K133242 STELLARIS VISION ENHANCEMENT SYSTEM
    K133146 BAUSCH + LUMB, VIS100 INJECTOR SYSTEM
    K132481 EASY-LOAD LENS DELIVERY SYSTEM
    K132593 CRYSTALSERT DELIVERY SYSTEM
    K123736 CRYSTALSERT DELIVERY SYSTEM
    K061157 SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
    K040913 NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)
    K020927 BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS