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

Octax LaserShot M

Name: Octax LaserShot M
Brand: Octax LaserShot M

The LaserShot M is a static laser system where the embryo is moved to the laser by moving the stage of the microscope. The LaserShot M components include a laser module (1.48 microm…

Registry build 21.09.26

The LaserShot M is a static laser system where the embryo is moved to the laser by moving the stage of the microscope. The LaserShot M components include a laser module (1.48 microm infrared diode laser, class 1M), laser adapter to connect to the microscope, mirror block, laser objective (25 times), USB camera, Eye Ware Software, and an optional target pointer and foot switch. The EyeWare software controls the device components, operates the laser, and takes images and records videos of embryo undergoing laser procedures. The software determines how many holes are drilled along this line and controls/restricts laser firing parameters to minimize localized heating of the embryo during these procedures. These laser devices have been designed to be fitted to compatible inverted microscopes.

1manufacturer

1catalogue number

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 Octax LaserShot M
Listed by	Octax Microscience GmbH
FDA product code	MRX
Device type	System, Assisted Reproduction Laser
Device class	Class 2
Regulation	21 CFR 884.6200
510(k)	K192008
Record published	2020-05-11

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Storage	Storage environment temperature -20 to 70 °C; Storage environment humidity 20 to 80 % RH; Handling environment atmospheric pressure 735 to 1060 millibar; Storage environment atmospheric pressure 735 to 1060 millibar; Handling environment humidity 20 to 80 % RH; Handling environment temperature -20 to 70 °C

Catalogue Numbers

Catalogue numbers for Octax LaserShot M
Catalogue number	Size	Status
19310/0148M		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Saturn 5 Laser System	Research Instruments Ltd	34
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
RI Saturn	Research Instruments Ltd	1

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.