510(k) · Cleared
ClearedZilos-TK, Version 3, Zilos-TK, Version 4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hamilton Thorne Biosciences · MRX System, Assisted Reproduction Laser
Cleared on Apr 28, 2005 after a 34-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Apr 28, 2005
- Review
- 34 days
- Class
- Class II
- Product code
- MRX
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK050768 Zilos-TK, Version 3, Zilos-TK, Version 4Hamilton Thorne Biosciences · 2005
- Descendant · cites it directly · 6 of its ownK060764 Saturn 3 Laser SystemResearch Instruments, Ltd. · 2007
- Descendant · 2 generations on · 4 of its ownK083208 Saturn Active Laser SystemResearch Instruments, Ltd. · 2009
- Descendant · 2 generations on · 3 of its ownK141434 Saturn 5 LaserResearch Instruments, Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK253333 Assisted Reproduction Laser System (Model ILS-400M)Hua Yue Medical Technology Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK202241 LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)Hamilton Thorne, Inc. · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K060764Saturn 3 Laser SystemResearch Instruments, Ltd. · 2007 · cites it directly6descendants
- K083208Saturn Active Laser SystemResearch Instruments, Ltd. · 2009 · 2 generations on4descendants
- K141434Saturn 5 LaserResearch Instruments, Ltd. · 2015 · 2 generations on3descendants
- K253333Assisted Reproduction Laser System (Model ILS-400M)Hua Yue Medical Technology Co., Ltd. · 2026 · 3 generations on0descendants
- K202241LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)Hamilton Thorne, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050768 | Zilos-TK, Version 3, Zilos-TK, Version 4 | Hamilton Thorne Biosciences | 2005 | — |
| +1 | K060764 | Saturn 3 Laser System | Research Instruments, Ltd. | 2007 | — |
| +2 | K083208 | Saturn Active Laser System | Research Instruments, Ltd. | 2009 | — |
| +2 | K141434 | Saturn 5 Laser | Research Instruments, Ltd. | 2015 | — |
| +3 | K253333 | Assisted Reproduction Laser System (Model ILS-400M) | Hua Yue Medical Technology Co., Ltd. | 2026 | — |
| +3 | K202241 | LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) | Hamilton Thorne, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060764 | Saturn 3 Laser System | 2007 | 6 |
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?
- Of its descendants, K060764 (Research Instruments, Ltd., 2007) has gone furthest, with 6 descendants of its own.
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 Hamilton Thorne ZILOS-tk is to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as:
Advanced maternal age
Prior failed IVF
Cryopreserved embryos
Abnormal zona pellucida morphology
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K050768 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050768: Zilos-TK, Version 3, Zilos-TK, Version 4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050768
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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