De Novo · Granted
GrantedHamilton Thorne Zona Infrared Laser Optical System (Zilos TK)
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
Granted on Nov 4, 2004 as a new device type through De Novo after a 71-day review. 4 later devices descend from it.
- Decided
- Nov 4, 2004
- Review
- 71 days
- Class
- Class II
- Product code
- MRX
- Recalls
- None
4 later devices descend from it, 2 citing it directly.
- This deviceDEN040009 Hamilton Thorne Zona Infrared Laser Optical System (Zilos TK)Hamilton Thorne Biosciences · 2004
- Descendant · cites it directly · 2 of its ownK062256 HF54 Combination Ultrasound Interferential and Premodulated…Hill Laboratories Co. · 2007
- Descendant · 2 generations on · 1 of its ownK072256 HF54 Combination Ultrasound Interferential and Premodulated…Hill Laboratories Co. · 2008
- Descendant · 3 generations on · 0 of its ownK090250 Electro-Light TherapyHill Laboratories Co. · 2010
- Descendant · cites it directly · 0 of its ownK062524 Octax Laser Shot SystemMinitube of America, Inc. · 2006
Most influential descendants
Showing 4 of 4 · See all- K062256HF54 Combination Ultrasound Interferential and Premodulated Stimulation SystemHill Laboratories Co. · 2007 · cites it directly2descendants
- K072256HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with…Hill Laboratories Co. · 2008 · 2 generations on1descendant
- K090250Electro-Light TherapyHill Laboratories Co. · 2010 · 3 generations on0descendants
- K062524Octax Laser Shot SystemMinitube of America, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN040009 | Hamilton Thorne Zona Infrared Laser Optical System (Zilos TK) | Hamilton Thorne Biosciences | 2004 | — |
| +1 | K062256 | HF54 Combination Ultrasound Interferential and Premodulated Stimulation System | Hill Laboratories Co. | 2007 | — |
| +2 | K072256 | HF54 Combination Ultrasound Interferential and Premodulated Stimulation System… | Hill Laboratories Co. | 2008 | — |
| +3 | K090250 | Electro-Light Therapy | Hill Laboratories Co. | 2010 | — |
| +1 | K062524 | Octax Laser Shot System | Minitube of America, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA De Novo database (decision fields), 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (4)
2 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?
- Of its descendants, K062256 (Hill Laboratories Co., 2007) has gone furthest, with 2 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 | — |
https://510kreport.com/device/DEN040009 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN040009: Hamilton Thorne Zona Infrared Laser Optical System (Zilos TK).” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN040009
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026