# K120055: Hanilton Thorne Infrared Laser Optical System-Zilos-TK  Hamilton Thorne Infrared Laser Optical System-Lykos

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Thorne, Inc.
- Decided: Apr 24, 2012 after 106 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063636: Zilos-TK, Hamilton Thorne Biosciences (2007) Summary page 1.
- K060764: Saturn 3 Laser System, Research Instruments, Ltd. (2007) Summary page 1.

## Indications for use
This system is intended 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 procedures, cryopreserved embryos, or abnormal zona pellucida morphology, and in IVF patients undergoing PGD to avoid genetic disease or aneuploidy.

Source page: https://510kreport.com/device/K120055
Methodology: https://510kreport.com/methodology