510(k) · Cleared
ClearedHanilton Thorne Infrared Laser Optical System-Zilos-TK Hamilton Thorne Infrared Laser Optical System-Lykos
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hamilton Thorne, Inc. · MRX System, Assisted Reproduction Laser
Cleared on Apr 24, 2012 as substantially equivalent to K063636 (Hamilton Thorne Biosciences, 2007) and 1 other predicate after a 106-day review. Its family tree reaches back 2 generations to 2005.
- Decided
- Apr 24, 2012
- Review
- 106 days
- Class
- Class II
- Product code
- MRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K050768 (2005). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K050768 | Zilos-TK, Version 3, Zilos-TK, Version 4 | Hamilton Thorne Biosciences | 2005 | — |
| −1 | K060764 | Saturn 3 Laser System | Research Instruments, Ltd. | 2007 | — |
| 0 (this device) | K120055 | Hanilton Thorne Infrared Laser Optical System-Zilos-TK Hamilton Thorne… | Hamilton Thorne, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K063636 | Zilos-TKSummary page 1…LYKOS: Assisted Reproduction Laser System, 884.6200: Product Code MRX E. Predicate Device(s) Hamilton Thorne Infrared Laser Optical system (Zilos-tk) (K063636) Research Instruments Saturn 3 laser system (K060764) F. Indications for Use This system is intended to be use… | 2007 |
| * | K060764 | Saturn 3 Laser SystemSummary page 1…Product Code MRX E. Predicate Device(s) Hamilton Thorne Infrared Laser Optical system (Zilos-tk) (K063636) Research Instruments Saturn 3 laser system (K060764) F. Indications for Use This system is intended to be used to drill a small tangential bole in or to thin the… | 2007 |
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 7 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All MRX devicesMRX System, Assisted Reproduction Laser: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
This system is intended 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 procedures, cryopreserved embryos, or abnormal zona pellucida morphology, and in IVF patients undergoing PGD to avoid genetic disease or aneuploidy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120055 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120055: Hanilton Thorne Infrared Laser Optical System-Zilos-TK Hamilton Thorne Infrared Laser Optical System-Lykos.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120055
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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