510(k) · Cleared
ClearedVISULAS yag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, Inc. · HQF Laser, Ophthalmic
Cleared on Sep 22, 2023 as substantially equivalent to K212630 (Ellex Medical Pty, Ltd., 2021) after a 225-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Sep 22, 2023
- Review
- 225 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K021550 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK021550 Lumenis Selecta DuetEllex Medical Pty, Ltd. · 2002
- 1 generation backK212630 Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, SoloEllex Medical Pty, Ltd. · 2021
- This deviceK230350 VISULAS yagCarl Zeiss Meditec, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK233911 VISULAS combiCarl Zeiss Meditec, AG · 2024
Most influential descendants
Showing 1 of 1 · See all- K233911VISULAS combiCarl Zeiss Meditec, AG · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021550 | Lumenis Selecta Duet | Ellex Medical Pty, Ltd. | 2002 | — |
| −1 | K212630 | Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo | Ellex Medical Pty, Ltd. | 2021 | — |
| 0 (this device) | K230350 | VISULAS yag | Carl Zeiss Meditec, Inc. | 2023 | — |
| +1 | K233911 | VISULAS combi | Carl Zeiss Meditec, AG | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 HQF? 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 HQF device
- #1 K251772 Navilas Laser System 577sl (156691)score 13.6 · 12 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 |
|---|---|---|---|
| * | K212630 | Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, SoloSummary page 5…II Product Code: HQF 3. PREDICATE DEVICE Predicate Device: Ellex YAG Laser (Ultra Q, Ultra Q Reflex) (K212630) Classification: 21CFR886.4390 Ophthalmic Laser Regulatory Class: II Product Code:… | 2021 |
| † | K042139 | Visulas Yag Iii | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233911 | VISULAS combi | 2024 | 0 |
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 21 years and passes through 2 companies; a new generation was cleared every 19.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K233911 (Carl Zeiss Meditec, AG, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K212630.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · HQF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQF
264in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQF
106in 2025
MAUDE reports naming product code HQF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 198 | 2 | 60 |
| 2008 | 3 | 28 | 1 | 34 |
| 2009 | 7 | 115 | 2 | 33 |
| 2010 | 2 | — | 3 | 43 |
| 2011 | 4 | 128 | 5 | 26 |
| 2012 | 5 | 179 | 1 | 41 |
| 2013 | 6 | 225 | 2 | 39 |
| 2014 | 3 | 215 | 4 | 58 |
| 2015 | 4 | 295 | 0 | 80 |
| 2016 | 3 | 271 | 0 | 108 |
| 2017 | 3 | 189 | 0 | 77 |
| 2018 | 1 | — | 0 | 82 |
| 2019 | 4 | 107 | 0 | 66 |
| 2020 | 4 | 53 | 0 | 72 |
| 2021 | 1 | — | 0 | 100 |
| 2022 | 7 | 86 | 0 | 111 |
| 2023 | 5 | 155 | 0 | 92 |
| 2024 | 3 | 167 | 0 | 75 |
| 2025 | 3 | 264 | 1 | 106 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
VISULAS yag is intended for use in photodisrupting ocular tissue in the treatment of diseases of the eye, including Posterior capsulotomy, Iridotomy and Posterior Membranectomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230350 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230350: VISULAS yag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230350
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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