510(k) · Cleared
ClearedTango Neo, Tango Reflex Neo, Ultra Q Reflex Neo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ellex Medical Pty, Ltd. · HQF Laser, Ophthalmic
Cleared on Nov 2, 2022 as substantially equivalent to K212630 (Ellex Medical Pty, Ltd., 2021) after an 86-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Nov 2, 2022
- Review
- 86 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K021550 (2002). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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…IV. Legally marketed Device /Predicate Device Device name: Ellex YAG/SLT (Tango/Tango Reflex/Ultra Q/Ultra Reflex/Solo) Premarket Notification: K212630 Manufacturer: Ellex Medical Pty Ltd V. Device Technological characteristics These devices are slit lamp based surgical… | 2021 |
| † | K063352 | Ellex Slit Lamp, Model 30XL | 2007 |
| † | K992836 | SL990, SL980, SL950 | 1999 |
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 20 years and passes through 1 company; a new generation was cleared every 19.4 years on median.
- None of the 2 ancestors has a recall.
- 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. 2022, 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?
In the YAG mode (Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo):
-Iridotomy and iridectomy.
-Posterior capsulotomy.
-Posterior membranectomy.
In the SLT mode (Tango Neo, Tango Reflex Neo) :
-Selective Laser Trabeculoplasty (SLT)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222395: Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222395
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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