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

    STELLARIS PC VISION ENHANCEMENT SYSTEM

    K Number: K133486 · Decision Mar 12, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    10
    Review Days
    119

    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
    STELLARIS PC VISION ENHANCEMENT SYSTEM
    K Number
    K133486
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bausch & Lomb
    Date Received
    November 13, 2013
    Decision Date
    March 12, 2014
    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 Bausch & Lomb

    K Number Device Name
    K133242 STELLARIS VISION ENHANCEMENT SYSTEM
    K131958 BAUSCH & LOMB INJECTOR 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