Octax LaserShot M - The LaserShot M is a static laser system where - Octax Microscience GmbH

Duns Number:314169074

Device Description: The LaserShot M is a static laser system where the embryo is moved to the laser by moving 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.

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More Product Details

Catalog Number

19310/0148M

Brand Name

Octax LaserShot M

Version/Model Number

19310/0148M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K192008

Product Code Details

Product Code

MRX

Product Code Name

System, Assisted Reproduction Laser

Device Record Status

Public Device Record Key

7ba123cb-3c78-4dd1-9c7f-4640fa05d7ee

Public Version Date

May 19, 2020

Public Version Number

1

DI Record Publish Date

May 11, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OCTAX MICROSCIENCE GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3