DeviceClearance

Product code MRX— Obstetrics/Gynecology

Assisted Reproduction Laser System (Model ILS-400M)

Classification name
System, Assisted Reproduction Laser
Device class
Class 2
Regulation
21 CFR 884.6200
Advisory panel
Obstetrics/Gynecology
Total cleared
11
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code MRX under 21 CFR 884.6200, via openFDA

Market context for product code MRX

FDA has cleared 11 devices under product code MRX between 2004 and 2026, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code MRX

Recent clearances under product code MRX

Data sourced from openFDA. This site is unofficial and independent of the FDA.