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

    xPORT S Lens Fragmentation System

    K Number: K200207 · Decision Oct 15, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    7
    Review Days
    261

    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
    xPORT S Lens Fragmentation System
    K Number
    K200207
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Carl Zeiss Meditec Cataract Technology, Inc.
    Date Received
    January 28, 2020
    Decision Date
    October 15, 2020
    Product Code
    HQC
    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
    HQC Unit, Phacofragmentation

    Similar 510(k) Clearances

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

    Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    System Sophi

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MICOR 700 with Auto I/A

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all

    Other Clearances by Carl Zeiss Meditec Cataract Technology, Inc.

    K Number Device Name
    K243395 MICOR 700 with Auto I/A
    K242801 MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)
    K214028 MICOR Lens Fragmentation System
    K222236 miCOR System Lens Fragmentation System
    K200584 xPORT 304 (miCOR) System Lens Fragmentation System
    K191024 xPORT Lens Fragmentation System