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. and Vitrolife GmbH.
11
Total
10
Cleared
200d
Avg days
2004
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
260d
recently vs 194d historically
FDA 510(k) Cleared System, Assisted Reproduction Laser Devices (Product Code MRX)
11 devices
Cleared
Jul 02, 2021
LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)
Hamilton Thorne, Inc.
Obstetrics & Gynecology
326d
Cleared
Mar 25, 2020
LaserShot M, NaviLase
Vitrolife GmbH
Obstetrics & Gynecology
240d
About Product Code MRX - Regulatory Context
510(k) Submission Activity
11 total 510(k) submissions under product code MRX since 2004, with 10 receiving FDA clearance (average review time: 200 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - MRX Product Code
Recent submissions under MRX have taken an average of 260 days to reach a decision - up from 194 days historically. Manufacturers should account for longer review timelines in current project planning.
MRX devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →