Octax NaviLase 19310/0146

GUDID 04260604170028

This submission includes two assisted reproduction laser systems, the LaserShot M and the NaviLase. 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 micrometer infrared diode laser, class 1M), laser adapter to connect to the microscope, mirror block, laser objective (25X), USB camera, EyeWare Software, and an optional target pointer and footswitch. The NaviLase includes the same components as the LaserShot M, but also includes a motion module and a motion controller. These additional components allow the NaviLase to work in two modes, fixed and dynamic. In fixed mode, the NaviLase operates similarly to the LaserShot M. In dynamic mode, the laser can be directed to any location within the field of view. In addition, dynamic mode allows automated laser firing along a user-defined path (straight line, arc, etc.). 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 Assisted reproduction laser system
Primary Device ID04260604170028
NIH Device Record Key9f7c6951-d158-4561-87a2-5dd318d2de0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOctax NaviLase
Version Model Number19310/0146
Catalog Number19310/0146
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
Phone+49876593990
Emailsupport.de@vitrolife.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104260604170028 [Primary]
GS104260604170028 [Primary]
GS104260604170028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRXSystem, Assisted Reproduction Laser
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 M2020-05-19 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 NaviLase2020-05-19This submission includes two assisted reproduction laser systems, the LaserShot M and the NaviLase. 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 micrometer infrared diode laser, class 1M), laser adapter to connect to the microscope, mirror block, laser objective (25X), USB camera, EyeWare Software, and an optional target pointer and footswitch. The NaviLase includes the same components as the LaserShot M, but also includes a motion module and a motion controller. These additional components allow the NaviLase to work in two modes, fixed and dynamic. In fixed mode, the NaviLase operates similarly to the LaserShot M. In dynamic mode, the laser can be directed to any location within the field of view. In addition, dynamic mode allows automated laser firing along a user-defined path (straight line, arc, etc.). 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.
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

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