510(k) · Cleared
ClearedSolutis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantel Medical · HQF Laser, Ophthalmic
Cleared on Aug 2, 2013 as substantially equivalent to K021550 (Ellex Medical Pty, Ltd., 2002) and 1 other predicate after a 120-day review. Its family tree reaches back 4 generations to 1989. 4 later devices descend from it.
- Decided
- Aug 2, 2013
- Review
- 120 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K894841 (1989). 14 ancestors in all, the oldest K812219 (1981). 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 3 generations backK960971 Oculight GLIriderm Div. · 1996
- 2 generations backK022181 Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2002
- 1 generation backK081704 Selecta Family of Ophithalmic Laser SystemsLumenis, Inc. · 2008
- This deviceK130933 SolutisQuantel Medical · 2013
- Descendant · cites it directly · 3 of its ownK140336 Optimus Fusion: SLT, Yag and Yag/SLTQuantel Medical · 2014
- Descendant · 2 generations on · 1 of its ownK192045 Ophthalmic Yag Laser System YC-200Nidek Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK220430 CapsuloQuantel Medical · 2022
- Descendant · 3 generations on · 0 of its ownK203130 Ophthalmic Yag Laser System YC-200Nidek Co., Ltd. · 2020
Most influential descendants
Showing 4 of 4 · See all- K140336Optimus Fusion: SLT, Yag and Yag/SLTQuantel Medical · 2014 · cites it directly3descendants
- K192045Ophthalmic Yag Laser System YC-200Nidek Co., Ltd. · 2019 · 2 generations on1descendant
- K220430CapsuloQuantel Medical · 2022 · 2 generations on0descendants
- K203130Ophthalmic Yag Laser System YC-200Nidek Co., Ltd. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −3 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −2 | K022181 | Novus Varia Ophthalmic Laser and Delivery Devices with Accessories | Lumenis, Inc. | 2002 | — |
| −1 | K081704 | Selecta Family of Ophithalmic Laser Systems | Lumenis, Inc. | 2008 | — |
| 0 (this device) | K130933 | Solutis | Quantel Medical | 2013 | — |
| +1 | K140336 | Optimus Fusion: SLT, Yag and Yag/SLT | Quantel Medical | 2014 | — |
| +2 | K192045 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. | 2019 | — |
| +2 | K220430 | Capsulo | Quantel Medical | 2022 | — |
| +3 | K203130 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K021550 | Lumenis Selecta DuetSummary page 2…Ophthalmology K130933 Page 2 of 2 3. Predicate Devices -Lumenis Selecta Duet (K02 1550) -Lumenis Family of Ophthalmic laser Systems, Model : Selecta SLT (K08 1704) 4. Device Description SOLUTIS is a Q-switche… | 2002 |
| * | K081704 | Selecta Family of Ophithalmic Laser SystemsSummary page 2…K130933 Page 2 of 2 3. Predicate Devices -Lumenis Selecta Duet (K02 1550) -Lumenis Family of Ophthalmic laser Systems, Model : Selecta SLT (K08 1704) 4. Device Description SOLUTIS is a Q-switched, frequency doubled Nd:YAG laser providing a wavelength of 532 nmn for us… | 2008 |
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 |
|---|---|---|---|
| K140336 | Optimus Fusion: SLT, Yag and Yag/SLT | 2014 | 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 24 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K140336 (Quantel Medical, 2014) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K021550.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Selective Laser Trabeculoplasty (SLT)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130933 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130933: Solutis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130933
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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