Octax NaviLase

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…

Registry build 21.09.26

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.

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 NaviLase
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 atmospheric pressure 735 to 1060 millibar; Handling environment atmospheric pressure 735 to 1060 millibar; Handling environment humidity 20 to 80 % RH; Handling environment temperature -20 to 70 °C; Storage environment humidity 20 to 80 % RH; Storage environment temperature -20 to 70 °C

Catalogue Numbers

Catalogue numbers for Octax NaviLase
Catalogue number Size Status
19310/0146 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
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
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer