# K063636: Zilos-TK

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Thorne Biosciences
- Decided: Apr 24, 2007 after 138 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K040451: Varelisa B2 Glycoprotein I Igm Antibodies, Models 18848 and 18896, Pharmacia Deutschland GmbH (2004). Our reading of the summary gave K040451, FDA’s number for Varelisa B2 Glycoprotein I Igm Antibodies, Models 18848… (Pharmacia Deutschland GmbH). Its FDA name has none of the distinctive words the summary uses for the device it names, “ZILOS-tk”. Kept off the family tree.

## Most influential descendants
- K120055: Hanilton Thorne Infrared Laser Optical System-Zilos-TK  Hamilton Thorne Infrared Laser Optical System-Lykos (2012), 0 descendants of its own

## 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/K063636
Methodology: https://510kreport.com/methodology