510(k) · Cleared
ClearedAssisted Reproduction Laser System (Model ILS-400M)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hua Yue Medical Technology Co., Ltd. · MRX System, Assisted Reproduction Laser
Cleared on Jun 17, 2026 as substantially equivalent to K141434 (Research Instruments, Ltd., 2015) after a 260-day review. Its family tree reaches back 4 generations to 2005.
- Decided
- Jun 17, 2026
- Review
- 260 days
- Class
- Class II
- Product code
- MRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K050768 (2005). No later device cites it as a predicate yet.
- Root · 4 generations backK050768 Zilos-TK, Version 3, Zilos-TK, Version 4Hamilton Thorne Biosciences · 2005
- 3 generations backK060764 Saturn 3 Laser SystemResearch Instruments, Ltd. · 2007
- 2 generations backK083208 Saturn Active Laser SystemResearch Instruments, Ltd. · 2009
- 1 generation backK141434 Saturn 5 LaserResearch Instruments, Ltd. · 2015
- This deviceK253333 Assisted Reproduction Laser System (Model ILS-400M)Hua Yue Medical Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K050768 | Zilos-TK, Version 3, Zilos-TK, Version 4 | Hamilton Thorne Biosciences | 2005 | — |
| −3 | K060764 | Saturn 3 Laser System | Research Instruments, Ltd. | 2007 | — |
| −2 | K083208 | Saturn Active Laser System | Research Instruments, Ltd. | 2009 | — |
| −1 | K141434 | Saturn 5 Laser | Research Instruments, Ltd. | 2015 | — |
| 0 (this device) | K253333 | Assisted Reproduction Laser System (Model ILS-400M) | Hua Yue Medical Technology Co., Ltd. | 2026 | — |
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 K202241 LYKOS Assisted Reproduction Laser with Dynamic…score 2.5 · 4 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K141434 | Saturn 5 LaserSummary page 5…Assisted Reproduction Laser System Product Code: MRX Review Panel: Obstetrics/Gynecology Regulatory Class: Ⅱ 4. Predicate Device Information 510(k) Number: K141434 Trade/Proprietary Name: Saturn 5 Laser System The predicate device has not been subject to a design-related recall. 5. De… | 2015 |
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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K141434.
How does its category compare?
All MRX devicesMRX System, Assisted Reproduction Laser: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253333: Assisted Reproduction Laser System (Model ILS-400M).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253333
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026