510(k) · Cleared
ClearedOctax Laser Shot System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minitube of America, Inc. · MRX System, Assisted Reproduction Laser
Cleared on Dec 15, 2006 as substantially equivalent to DEN040009 (Hamilton Thorne Biosciences, 2004) after a 109-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Dec 15, 2006
- Review
- 109 days
- Class
- Class II
- Product code
- MRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN040009 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backDEN040009 Hamilton Thorne Zona Infrared Laser Optical System (Zilos TK)Hamilton Thorne Biosciences · 2004
- This deviceK062524 Octax Laser Shot SystemMinitube of America, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN040009 | Hamilton Thorne Zona Infrared Laser Optical System (Zilos TK) | Hamilton Thorne Biosciences | 2004 | — |
| 0 (this device) | K062524 | Octax Laser Shot System | Minitube of America, Inc. | 2006 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MRX device
- #1 K253333 Assisted Reproduction Laser System (Model…score 12.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN040009 | Hamilton Thorne Zona Infrared Laser Optical System (Zilos TK) 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. | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN040009.
How does its category compare?
All MRX devicesMRX System, Assisted Reproduction Laser: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MRX
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · MRX
Too few MRX 510(k)s in any year since 2007 to give a median.
Recalls per year · MRX
No recall names MRX since 2007.
Adverse event reports per year · MRX
No MAUDE report names MRX since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062524 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062524: Octax Laser Shot System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062524
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026