# K253333: Assisted Reproduction Laser System (Model ILS-400M)

- Pathway: 510(k) (Traditional)
- Applicant: Hua Yue Medical Technology Co., Ltd.
- Decided: Jun 17, 2026 after 260 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 5.

## Indications for use
The Assisted Reproduction Laser System (Model ILS-400M) is for use in assisted reproduction procedures to ablate or thin the zona pellucida of an embryo to facilitate assisted hatching or recovery of cells for pre-implantation genetic diagnosis (blastomeres). The device can also be used on blastocyst stage embryos for biopsy of trophectoderm cells for pre-implantation diagnosis procedures, and blastocyst collapse prior to vitrification procedures.

Source page: https://510kreport.com/device/K253333
Methodology: https://510kreport.com/methodology