BEUDAMED
    Product Code: MRX FDA class 2 21 CFR 884.6200

    System, Assisted Reproduction Laser

    Obstetrics/Gynecology

    The Assisted Reproduction Laser System is an obstetrics/gynecology device that uses laser energy to perform zona pellucida drilling or thinning (assisted hatching) on embryos in selected IVF patients who have poor prognosis for successful pregnancy, such as those of advanced maternal age, prior failed IVF cycles, or with cryopreserved or morphologically abnormal embryos. Classified as FDA Class 2 under 21 CFR 884.6200, it requires 510(k) premarket notification. The product code is MRX.

    View on FDA
    510(k)s
    11
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    6
    Years Active
    22

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    Basic Information

    Product Code
    MRX
    Device Class
    FDA class 2
    Regulation Number
    884.6200
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    1

    Device Characteristics

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

    Definition

    This system is inteded to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization patients with otherwise poor prognois for successful pregnancy outcome, such as advanced maternal age, prior failed in vitro fertilization procedures, cryopreserved embryos, or abnormal zona pellucida morphology.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 11 510(k) clearances via K numbers.

    K Number Device Name
    K253333 Assisted Reproduction Laser System (Model ILS-400M)
    K202241 LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)
    K192008 LaserShot M, NaviLase
    K141434 SATURN 5 LASER
    K120055 HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS
    K083208 SATURN ACTIVE LASER SYSTEM
    K063636 ZILOS-TK
    K060764 SATURN 3 LASER SYSTEM
    K062524 OCTAX LASER SHOT SYSTEM
    K050768 ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4
    DEN040009 HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.