MRX · Class II · 21 CFR 884.6200

FDA Product Code MRX: System, Assisted Reproduction Laser

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.

Leading manufacturers include Hamilton Thorne, Inc..

10
Total
9
Cleared
194d
Avg days
2004
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared System, Assisted Reproduction Laser Devices (Product Code MRX)

10 devices
1–10 of 10
Cleared Jul 02, 2021
LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)
K202241
Hamilton Thorne, Inc.
Obstetrics & Gynecology · 326d

About Product Code MRX - Regulatory Context

510(k) Submission Activity

10 total 510(k) submissions under product code MRX since 2004, with 9 receiving FDA clearance (average review time: 194 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

MRX devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →