BEUDAMED
    Product Code: MSS FDA class 1 21 CFR 886.4300

    Folders And Injectors, Intraocular Lens (Iol)

    Ophthalmic

    Intraocular Lens (IOL) Folders and Injectors are surgical instruments used to fold and insert foldable intraocular lenses into the eye during cataract surgery, enabling minimally invasive lens delivery through a small incision. They are classified as FDA Class 1, subject to general controls only, with product code MSS under 21 CFR 886.4300 in the Ophthalmic specialty. No premarket notification is required. These devices are not implants themselves and are not life-sustaining.

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    510(k)s
    61
    FEI Numbers
    46
    Registration Numbers
    46
    Unique Applicants
    33
    Years Active
    27

    Basic Information

    Product Code
    MSS
    Device Class
    FDA class 1
    Regulation Number
    886.4300
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 61 510(k) clearances via K numbers.

    K Number Device Name
    K242389 EyeGility™ Inserter for Preloaded enVista IOLs
    K231106 Accuject Refra Injector AR2900
    K231838 RxSight® Insertion Device (63002)
    K231466 RxSight Insertion Device
    K212039 CLAREON MONARCH IV IOL Delivery System
    K200057 bioli lOL Delivery System
    K192926 RxSight Insertion Device
    K192005 Bausch + Lomb PreVue Inserter for enVista Preloaded
    K191949 UNFOLDER Vitan Inserter
    K182965 BL-Cart IOL Delivery Cartridge
    K181401 RxSight Insertion Device
    K172228 pioli IOL Delivery System
    K173480 Crystalsert Lens Delivery System
    K172375 MicroSTAAR Injector System Cartridges
    K161776 Lenstec LC Injection system
    K161012 Easy-Load Lens Delivery System
    K151102 Bausch + Lomb Injector System
    K143434 One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
    K142056 LIOLI IOL DELIVERY SYSTEM
    K143307 RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector
    K141091 RAYSERT PLUS INJECTOR
    K132002 SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR
    K131958 BAUSCH & LOMB INJECTOR SYSTEM
    K133146 BAUSCH + LUMB, VIS100 INJECTOR SYSTEM
    K132481 EASY-LOAD LENS DELIVERY SYSTEM
    K122848 LENSTEC LC INJECTION SYSTEM
    K132593 CRYSTALSERT DELIVERY SYSTEM
    K123736 CRYSTALSERT DELIVERY SYSTEM
    K123888 Z CARTRIDGE IOL DELIVERY SYSTEM
    K113852 BAUSCH & LOMB IOL INJECTOR
    K112977 MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)
    K101774 MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)
    K103495 ASICO SOFTIP INJECTOR SYSTEM
    K101782 MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE
    K101134 VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430
    K091507 RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18
    K092023 NAVIJECT SUB2-1P, MODEL: LP604430
    K082871 XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM
    K090161 EPIPHANY INJECTION SYSTEM
    K081346 HOYA IS INJECTOR SYSTEM
    K082944 CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
    K081545 ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30
    K081455 RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06
    K073591 MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
    K073586 MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM
    K073010 ROYALE AE 9036 LSP INJECTOR
    K063802 LENSTEC LC INJECTION SYSTEM
    K062612 RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04
    K060995 DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788
    K060533 LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM
    K053176 DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797
    K052651 C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02
    K050638 LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES
    K040837 MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE
    K024072 DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM
    K023737 INJECTOR
    K011392 MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER
    K003768 MONARCH II IOL DELIVERY SYSTEM
    K002556 CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
    K980696 FOAM TIP INJECTOR
    K970727 MPORT FOLDABLE LENS PLACEMENT SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 46 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 46 registration numbers. Click on an entry to view related FDA registrations.