Octax LaserShot M 19310/0148M

GUDID 04260604170011

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.

Octax Microscience GmbH

Assisted reproduction laser system Assisted reproduction laser system
Primary Device ID04260604170011
NIH Device Record Key7ba123cb-3c78-4dd1-9c7f-4640fa05d7ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameOctax LaserShot M
Version Model Number19310/0148M
Catalog Number19310/0148M
Company DUNS314169074
Company NameOctax Microscience GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49876593990
Emailsupport.de@vitrolife.com
Phone+49876593990
Emailsupport.de@vitrolife.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 735 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 735 millibar and 1060 millibar
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 735 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 735 millibar and 1060 millibar
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104260604170011 [Primary]
GS104260604170011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRXSystem, Assisted Reproduction Laser
MRXSystem, Assisted Reproduction Laser

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

Devices Manufactured by Octax Microscience GmbH

04260604170011 - Octax LaserShot M2020-05-19The 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.
04260604170011 - Octax LaserShot M2020-05-19 The LaserShot M is a static laser system where the embryo is moved to the laser by moving the stage of the microscope. The Laser
04260604170028 - Octax NaviLase2020-05-19 This submission includes two assisted reproduction laser systems, the LaserShot M and the NaviLase. The LaserShot M is a static
04260502101483 - OCTAX Laser Shot2019-05-03

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.