BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇭 Switzerland

    ACCUJECT Injector Set 2.1-1P (LP604590)

    K Number: K252540 · Decision Sep 16, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    62
    Applicant Total
    6
    Review Days
    35

    Basic Information

    Device Name
    ACCUJECT Injector Set 2.1-1P (LP604590)
    K Number
    K252540
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4300
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medicel AG
    Date Received
    August 12, 2025
    Decision Date
    September 16, 2025
    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

    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

    CLAREON MONARCH IV IOL Delivery System

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

    Other Clearances by Medicel AG

    K Number Device Name
    K231106 Accuject Refra Injector AR2900
    K101134 VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430
    K092023 NAVIJECT SUB2-1P, MODEL: LP604430
    K070669 IOL INJECTOR SET
    K040837 MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE