510(k) · Cleared
ClearedSaturn Active 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 Aug 25, 2009 as substantially equivalent to K060764 (Research Instruments, Ltd., 2007) after a 298-day review. Its family tree reaches back 2 generations to 2005. 4 later devices descend from it.
- Decided
- Aug 25, 2009
- Review
- 298 days
- Class
- Class II
- Product code
- MRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K050768 (2005). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK050768 Zilos-TK, Version 3, Zilos-TK, Version 4Hamilton Thorne Biosciences · 2005
- 1 generation backK060764 Saturn 3 Laser SystemResearch Instruments, Ltd. · 2007
- This deviceK083208 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
Most influential descendants
Showing 4 of 4 · See all- 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 |
|---|---|---|---|---|---|
| −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) | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K060764 | Saturn 3 Laser SystemSummary page 1…X Identification of Predicate Device [21CFR807.92(a)(3) Substantial Equivalence to Research Instruments Ltd. Saturn 3 Laser System Predicate 510(k) No. K060764 Description of the device [21 CFR807.92(a)(4] The Saturn Active Laser System is a device that images, targets, and contro… | 2007 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141434 | Saturn 5 Laser | 2015 | 3 |
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 4 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K141434 (Research Instruments, Ltd., 2015) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K060764.
How does its category compare?
All MRX devicesMRX System, Assisted Reproduction Laser: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Saturn Active is. a 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/K083208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083208: Saturn Active Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083208
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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