# K192008: LaserShot M, NaviLase

- Pathway: 510(k) (Abbreviated)
- Applicant: Vitrolife GmbH
- Decided: Mar 25, 2020 after 240 days
- Product code: MRX (System, Assisted Reproduction Laser)
- Device class: 2
- Regulation: 21 CFR 884.6200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K050768 (2005). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141434: Saturn 5 Laser, Research Instruments, Ltd. (2015) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K192008
Methodology: https://510kreport.com/methodology