# K202241: LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Thorne, Inc.
- Decided: Jul 2, 2021 after 326 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: 4 generations back to K050768 (2005). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141434: Saturn 5 Laser, Research Instruments, Ltd. (2015) Summary page 4.

## Indications for use
The LYKOS Assisted Reproduction Laser with Dynamic Target System (DTS) is intended for in vitro fertilization (IVF) laboratory use in assisted reproduction procedures to ablate a small, tangential hole or thin the zona pellucida of select IVF embryos to facilitate assisted reproduction hatching procedures and to biopsy trophectoderm cells from blastocyst stage embryos for purposes of preimplantation genetic diagnosis or screening.

Source page: https://510kreport.com/device/K202241
Methodology: https://510kreport.com/methodology