# K050768: Zilos-TK, Version 3, Zilos-TK, Version 4

- Pathway: 510(k) (Special)
- Applicant: Hamilton Thorne Biosciences
- Decided: Apr 28, 2005 after 34 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
No predicates in its family tree.
7 later devices descend from it; 1 cites 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K060764: Saturn 3 Laser System (2007), 6 descendants of its own
- 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

## Indications for use
The Hamilton Thorne ZILOS-tk 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/K050768
Methodology: https://510kreport.com/methodology