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 ID: 04260604170028
• NIH Device Record Key: 9f7c6951-d158-4561-87a2-5dd318d2de0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Octax NaviLase
• Version Model Number: 19310/0146
• Catalog Number: 19310/0146
• Company DUNS: 314169074
• Company Name: Octax Microscience GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49876593990
• Email: support.de@vitrolife.com
• Phone: +49876593990
• Email: support.de@vitrolife.com
• Phone: +49876593990
• Email: support.de@vitrolife.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 735 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 735 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 735 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 735 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 735 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 735 millibar and 1060 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260604170028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192008

FDA Product Code

• MRX: System, Assisted Reproduction Laser

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-19
• Device Publish Date: 2020-05-11

Devices Manufactured by Octax Microscience GmbH

• 04260604170011 - Octax LaserShot M: 2020-05-19 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 NaviLase: 2020-05-19This 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 NaviLase: 2020-05-19 This submission includes two assisted reproduction laser systems, the LaserShot M and the NaviLase. The LaserShot M is a static
• 04260502101483 - OCTAX Laser Shot: 2019-05-03