# K083208: Saturn Active Laser System

- Pathway: 510(k) (Abbreviated)
- Applicant: Research Instruments, Ltd.
- Decided: Aug 25, 2009 after 298 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: 2 generations back to K050768 (2005). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060764: Saturn 3 Laser System, Research Instruments, Ltd. (2007) Summary page 1.

## Most influential descendants
- 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
Saturn Active is. a 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/K083208
Methodology: https://510kreport.com/methodology