MRX

System, Assisted Reproduction Laser

Product code

MRX

Device name

System, Assisted Reproduction Laser

Device class

Class 2

21 CFR

21 CFR 884.6200

Medical specialty

Obstetrics/Gynecology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

11 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-06-17.

1 summaries are archived here for direct download.