# K060764: Saturn 3 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Research Instruments, Ltd.
- Decided: Mar 12, 2007 after 356 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: 1 generation back to K050768 (2005). 1 ancestor in all.
6 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050768: Zilos-TK, Version 3, Zilos-TK, Version 4, Hamilton Thorne Biosciences (2005) Summary page 1.

## Most influential descendants
- K083208: Saturn Active Laser System (2009), 4 descendants of its own
- K141434: Saturn 5 Laser (2015), 3 descendants of its own
- K253333: Assisted Reproduction Laser System (Model ILS-400M) (2026), 0 descendants of its own
- K202241: LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) (2021), 0 descendants of its own
- K192008: LaserShot M, NaviLase (2020), 0 descendants of its own

## Indications for use
The Saturn 3 Laser System is to be used to drill a small tangential hole in, or to thin, the zona pellucida of the embryo in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as: Advanced maternal age Prior failed IVF Cryopreserved embryos Abnormal zona pellucida morphology

Source page: https://510kreport.com/device/K060764
Methodology: https://510kreport.com/methodology