BEUDAMED
    Product Code: OOE FDA class 2 21 CFR 886.4390

    Ophthalmic Femtosecond Laser

    Ophthalmic

    The Ophthalmic Femtosecond Laser (product code OOE) is a Class 2 ophthalmic device regulated under 21 CFR 886.4390 in the Ophthalmic specialty (OP), cleared via 510(k). It is used for precise cutting or ablation of ocular tissue, specifically indicated for anterior capsulotomy during cataract surgery, enabling highly accurate circular incisions in the lens capsule. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    47
    FEI Numbers
    29
    Registration Numbers
    29
    Unique Applicants
    12
    Years Active
    16

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    Basic Information

    Product Code
    OOE
    Device Class
    FDA class 2
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    1

    Device Characteristics

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

    Definition

    Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 47 510(k) clearances via K numbers.

    K Number Device Name
    K252682 LenSx Laser System (8065000944)
    K243896 LenSx Laser System (8065998162)
    K223566 ELITA™ Femtosecond Laser System, ELITA™ Patient Interface
    K223838 Catalys™ Precision Laser System
    K220259 ALLY Adaptive Cataract Treatment System
    K220516 CATALYS Precision Laser system
    K213559 FEMTO LDV Z8 Femtosecond Surgical Laser
    K210701 CATALYS Precision Laser System
    K200724 VICTUS Femtosecond Laser Platform
    K200056 Catalys Precision Laser System
    K182795 LENSAR Laser System - fs 3D (LLS-fs 3D)
    K182083 Catalys Precision Laser System
    K181430 LENSAR Laser System - fs 3D (LLS-fs 3D)
    K173660 LenSx Laser System
    K173346 LENSAR Laser System - fs 3D (LLS-fs 3D)
    K171014 VICTUS Femtosecond Laser Platform
    K172002 Catalys Precision Laser System
    K171337 LENSAR Laser System – fs 3D (LLS-fs 3D)
    K170322 Catalys Precision Laser System
    K170576 LENSAR Laser System - fs 3D (LLS-fs 3D)
    K163551 LenSx Laser System
    K161288 LenSX Laser System
    K161455 Catalys Precision Laser System
    K150323 FEMTO LDV Z8 Surgical Laser
    K152453 LENSAR Laser System - fs 3D (LLS-fs 3D)
    K151161 VICTUS Femtosecond Laser Platform
    K143010 LENSAR Laser System - fs 3D
    K141379 VICTUS FEMTOSECOND LASER PLATFORM
    K141476 WAVELIGHT FS200 LASER SYSTEM
    K141079 OPTIMEDICA CATALYS PRECISION LASER SYSTEM
    K140615 VICTUS FEMTOSECOND LASER PLATFORM
    K132534 VICTUS FEMTOSECOND LASER PLATFORM
    K123859 TBD
    K122386 VICTUS FEMTOSECOND LASER PLATFORM
    K123120 LENSX LASER SYSTEM
    K121091 CATALYS PRECISION LASER SYSTEM
    K120426 VICTUS LASER PLATFORM
    K120214 TBD
    K113479 OPTIMEDICA CATALYS PRECISION LASER SYSTEM
    K110427 FEMTEC LASER SYSTEM FOR CAPSULOTOMY
    K112098 TBD
    K102727 LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY
    K101626 LENSX LASER SYSTEM
    K090633 LENSAR LASER SYSTEM
    K094052 LENSX 550 LASER SYSTEM. MODEL 550
    K092647 LENSX 550 LASER SYSTEM
    K082947 LENSX 550 LASER SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 29 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 29 registration numbers. Click on an entry to view related FDA registrations.