LaserShot M, NaviLase
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- LaserShot M EUDAMEDOctax LaserShot M FDA UDI
- Generic Name
- Assisted reproduction laser system FDA UDI
- Device Name
- Octax LaserShot M EUDAMEDThe 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. FDA UDI
- Model / Reference
- 19310/0148M EUDAMEDFDA UDIOctax LaserShot M EUDAMED
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 19310/0148M FDA UDI
- Primary DI / UDI-DI
- 04260604170011 EUDAMEDFDA UDI
- Basic UDI-DI
- 4260604170015G EUDAMED
- 510(k) Number
- FDA Product Code
- MRX FDA 510(k)FDA UDI
- EMDN Code
- Z12080205 OOCYTE LASER DRILLS EUDAMED
- GMDN Term
- Assisted reproduction laser system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 884.6200 FDA 510(k)
- Regulation Number
- 884.6200 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The LaserShot M and NaviLase are System, Assisted Reproduction Laser devices designed for laser-assisted hatching or zona pellucida thinning in assisted reproductive technology (ART). These systems employ a 1.48 µm infrared diode laser to create precise micro-abrasions on embryo surfaces, aiding implantation potential during in vitro fertilization (IVF) procedures. Both devices are classified under Device Class II and fall under regulatory category MRX for obstetrics/gynecology applications.
The LaserShot M is a static laser system where the embryo is positioned under a microscope stage for laser exposure, while the NaviLase incorporates dynamic laser guidance. Both are single-use components (laser modules) supplied with reusable system hardware, requiring installation and training by authorized Vitrolife technicians. They are non-MRI-safe and must be stored in compliance with laser safety protocols. Authorized under FDA 510(k) clearance and MDR compliance, these devices are intended exclusively for use in clinical ART settings.
Frequently asked questions
What is the primary clinical purpose of the LaserShot M and NaviLase systems in assisted reproductive technology (ART) procedures?
The LaserShot M and NaviLase systems are designed specifically for laser-assisted hatching or zona pellucida thinning during IVF. These procedures involve creating precise micro-abrasions on embryo surfaces to potentially improve implantation rates by facilitating embryo escape from the zona pellucida. The systems use a 1.48 µm infrared diode laser to achieve this, ensuring controlled and targeted intervention.
Are the laser modules for these devices single-use or reusable, and what does that mean for my lab’s workflow?
The laser modules for both the LaserShot M and NaviLase are single-use components, while the core system hardware (e.g., microscope stage, controls) is reusable. This means each module must be replaced after one use, reducing contamination risks and ensuring consistent performance. Your lab will need to order replacement modules as needed, and the reusable hardware requires installation and training by Vitrolife-authorized technicians.
How should these devices be stored, and are there any special handling requirements due to their laser technology?
The LaserShot M and NaviLase must be stored in accordance with laser safety protocols, as they are not MRI-safe. This likely includes secure storage for the laser modules (e.g., in a controlled environment away from direct sunlight or moisture) and adherence to manufacturer guidelines for the reusable system components. Always follow Vitrolife’s instructions to maintain functionality and safety.
What distinguishes the NaviLase from the LaserShot M in terms of how the laser is applied?
The LaserShot M uses a static laser system, where the embryo is positioned under a microscope stage for direct laser exposure. In contrast, the NaviLase incorporates dynamic laser guidance, which likely involves automated or semi-automated adjustments to enhance precision during the procedure. This difference may affect workflow efficiency and ease of use depending on your lab’s preferences.
What regulatory pathways have these devices undergone, and how does that affect their use in clinical settings?
Both the LaserShot M and NaviLase have received FDA 510(k) clearance and comply with MDR (Medical Device Regulation) standards. This means they are classified as Class II devices under the FDA and fall under the MRX product code for obstetrics/gynecology applications. Their regulatory status confirms they meet safety and performance requirements for use exclusively in clinical ART settings, as intended by Vitrolife.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Octax LaserShot M TM Octax NaviLase User Manual - Vitrolife, VITROLIFE OCTAX LASERSHOT M USER MANUAL Pdf Download, LaserShot M, NaviLase by Vitrolife GmbH | FDA 510(k) Summary
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K192008 | Class II | Active |
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Manufacturer
- Manufacturer
- Vitrolife GmbH
Sources (3)
- FDA 510(k) K192008 24 fields · synced Sep 18, 2026
- FDA UDI 7ba123cb-3c78-4dd1-9c7f-4640fa05d7ee 37 fields · synced May 25, 2026
- EUDAMED 6d118680-0307-4cc4-807e-4cc09dcbee38 61 fields · synced Jul 24, 2026