# K062524: Octax Laser Shot System

- Pathway: 510(k) (Abbreviated)
- Applicant: Minitube of America, Inc.
- Decided: Dec 15, 2006 after 109 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: 1 generation back to DEN040009 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN040009: Hamilton Thorne Zona Infrared Laser Optical System (Zilos TK), Hamilton Thorne Biosciences (2004). Our reading of the summary gave K040045, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN040009, Hamilton Thorne Zona Infrared Laser Optical System (Zilos… (Hamilton Thorne Biosciences), granted Nov 4, 2004; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Indications for use
The OCTAX Laser ShotTM is a laser system for microsurgery on a cellular level, which works on a semiconductor basis. It is intended to be used to ablate a small tangential hole in the zona pellucida (assisted hatching) to be performed immediately prior to transfer on day 2 or day 3 in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as those with advanced maternal age, prior failed IVF, cryopreserved embryos, or abnormal zona pellucida characteristics. For safety reasons, the system should only be used if more than one embryo is available for transfer.

Source page: https://510kreport.com/device/K062524
Methodology: https://510kreport.com/methodology