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System, Assisted Reproduction Laser

FDA product code MRX · 9 cleared devices

Class 2 Obstetrics/Gynecology
Regulation
21 CFR 884.6200
Review panel
OB
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2005-04-28 – 2026-06-17

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.

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