510(k) · Cleared
ClearedSaturn 3 Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Research Instruments, Ltd. · MRX System, Assisted Reproduction Laser
Cleared on Mar 12, 2007 as substantially equivalent to K050768 (Hamilton Thorne Biosciences, 2005) after a 356-day review. Its family tree reaches back 1 generation to 2005. 6 later devices descend from it.
- Decided
- Mar 12, 2007
- Review
- 356 days
- Class
- Class II
- Product code
- MRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K050768 (2005). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK050768 Zilos-TK, Version 3, Zilos-TK, Version 4Hamilton Thorne Biosciences · 2005
- This deviceK060764 Saturn 3 Laser SystemResearch Instruments, Ltd. · 2007
- Descendant · cites it directly · 4 of its ownK083208 Saturn Active Laser SystemResearch Instruments, Ltd. · 2009
- Descendant · cites it directly · 3 of its ownK141434 Saturn 5 LaserResearch Instruments, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK253333 Assisted Reproduction Laser System (Model ILS-400M)Hua Yue Medical Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK202241 LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)Hamilton Thorne, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK192008 LaserShot M, NaviLaseVitrolife GmbH · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K083208Saturn Active Laser SystemResearch Instruments, Ltd. · 2009 · cites it directly4descendants
- K141434Saturn 5 LaserResearch Instruments, Ltd. · 2015 · cites it directly3descendants
- K253333Assisted Reproduction Laser System (Model ILS-400M)Hua Yue Medical Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K202241LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)Hamilton Thorne, Inc. · 2021 · 2 generations on0descendants
- K192008LaserShot M, NaviLaseVitrolife GmbH · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K050768 | Zilos-TK, Version 3, Zilos-TK, Version 4 | Hamilton Thorne Biosciences | 2005 | — |
| 0 (this device) | K060764 | Saturn 3 Laser System | Research Instruments, Ltd. | 2007 | — |
| +1 | K083208 | Saturn Active Laser System | Research Instruments, Ltd. | 2009 | — |
| +1 | K141434 | Saturn 5 Laser | Research Instruments, Ltd. | 2015 | — |
| +2 | K253333 | Assisted Reproduction Laser System (Model ILS-400M) | Hua Yue Medical Technology Co., Ltd. | 2026 | — |
| +2 | K202241 | LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) | Hamilton Thorne, Inc. | 2021 | — |
| +2 | K192008 | LaserShot M, NaviLase | Vitrolife GmbH | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K050768 | Zilos-TK, Version 3, Zilos-TK, Version 4Summary page 1…tion Number: 21CFR884.6200 Product Code: MRX Identification of Predicate Device [21 CFR8O7.92(a)(3)] Substantial Equivalence to Hamilton Thorne Zilos-tk (K050768) Description of the Device [21 CFR8O7.92(a)(4)] The Saturn 3 Laser System is a device that images, targets, and controls… | 2005 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- Of its descendants, K083208 (Research Instruments, Ltd., 2009) has gone furthest, with 4 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. 2007, 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 Saturn 3 Laser System 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 summary.
https://510kreport.com/device/K060764 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060764: Saturn 3 Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060764
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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