510(k) · Cleared
ClearedLaserShot M, NaviLase
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitrolife GmbH · MRX System, Assisted Reproduction Laser
Cleared on Mar 25, 2020 as substantially equivalent to K141434 (Research Instruments, Ltd., 2015) after a 240-day review. Its family tree reaches back 4 generations to 2005.
- Decided
- Mar 25, 2020
- Review
- 240 days
- Class
- Class II
- Product code
- MRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K050768 (2005). No later device cites it as a predicate yet.
- Root · 4 generations backK050768 Zilos-TK, Version 3, Zilos-TK, Version 4Hamilton Thorne Biosciences · 2005
- 3 generations backK060764 Saturn 3 Laser SystemResearch Instruments, Ltd. · 2007
- 2 generations backK083208 Saturn Active Laser SystemResearch Instruments, Ltd. · 2009
- 1 generation backK141434 Saturn 5 LaserResearch Instruments, Ltd. · 2015
- This deviceK192008 LaserShot M, NaviLaseVitrolife GmbH · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K050768 | Zilos-TK, Version 3, Zilos-TK, Version 4 | Hamilton Thorne Biosciences | 2005 | — |
| −3 | K060764 | Saturn 3 Laser System | Research Instruments, Ltd. | 2007 | — |
| −2 | K083208 | Saturn Active Laser System | Research Instruments, Ltd. | 2009 | — |
| −1 | K141434 | Saturn 5 Laser | Research Instruments, Ltd. | 2015 | — |
| 0 (this device) | K192008 | LaserShot M, NaviLase | Vitrolife GmbH | 2020 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MRX device
- #1 K253333 Assisted Reproduction Laser System (Model…score 12.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141434 | Saturn 5 LaserSummary page 4…MRX (System, Assisted Reproduction Laser) Regulatory Class II Predicate device 510(k) number K141434 Device name Saturn 5™ Laser Systems Manufacturer Researc… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K141434.
How does its category compare?
All MRX devicesMRX System, Assisted Reproduction Laser: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MRX
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · MRX
Too few MRX 510(k)s in any year since 2007 to give a median.
Recalls per year · MRX
No recall names MRX since 2007.
Adverse event reports per year · MRX
No MAUDE report names MRX since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
For use in assisted reproduction procedures to ablate or thin the zona pellucida of an embryo to facilitate assisted hatching or recovery of cells for pre-implantation genetic diagnosis (blastomeres). The device can also be used on blastocyst stage embryos for biopsy of trophectoderm cells for preimplantation diagnosis procedures, and blastocyst collapse prior to vitrification procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192008: LaserShot M, NaviLase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192008
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026