What is FDA product code MRX?

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.

Obstetrics & Gynecology › MiscellaneousSystem, Assisted Reproduction Laser

RI Saturn

Name: RI Saturn
Brand: RI Saturn

RI Saturn 5 Active Zeiss Axiovert 5 40x obj

Registry build 21.09.26

1manufacturer

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code MRX
Manufacturer	City	Province	Registered as	Device types
HUA YUE Medical Technology Co., Ltd.	Guangzhou	Guangdong	Manufacturer	7

Record

Regulatory record for RI Saturn
Listed by	Research Instruments Ltd, United Kingdom
FDA product code	MRX
Device type	System, Assisted Reproduction Laser
Device class	Class 2
Regulation	21 CFR 884.6200
Establishment	Contract manufacturer, Manufacturer
510(k)	K141434
Record published	2026-07-14

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Distribution end date	2026-07-14

Catalogue Numbers

Catalogue numbers for RI Saturn
Catalogue number	Size	Status
6-47-500-29		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Saturn 5 Laser System	Research Instruments Ltd	34
Octax LaserShot M	Octax Microscience GmbH	1
Lykos™	Hamilton Thorne, Inc.	1
Lykos DTS	Hamilton Thorne, Inc.	1
Octax Laser Shot	Octax Microscience GmbH	1
ZILOS-tk™	Hamilton Thorne, Inc.	1
Octax NaviLase	Octax Microscience GmbH	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K141434	2015-02-18
K083208	2009-08-25
K060764	2007-03-12

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.