510(k) · Cleared
ClearedOptimus Fusion: SLT, Yag and Yag/SLT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantel Medical · HQF Laser, Ophthalmic
Cleared on Jun 25, 2014 as substantially equivalent to K081704 (Lumenis, Inc., 2008) and 2 other predicates after a 135-day review. Its family tree reaches back 5 generations to 1989. 3 later devices descend from it.
- Decided
- Jun 25, 2014
- Review
- 135 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K894841 (1989). 16 ancestors in all, the oldest K812219 (1981). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 4 generations backK960971 Oculight GLIriderm Div. · 1996
- 3 generations backK022181 Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2002
- 2 generations backK081704 Selecta Family of Ophithalmic Laser SystemsLumenis, Inc. · 2008
- 1 generation backK130933 SolutisQuantel Medical · 2013
- This deviceK140336 Optimus Fusion: SLT, Yag and Yag/SLTQuantel Medical · 2014
- Descendant · cites it directly · 1 of its ownK192045 Ophthalmic Yag Laser System YC-200Nidek Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK220430 CapsuloQuantel Medical · 2022
- Descendant · 2 generations on · 0 of its ownK203130 Ophthalmic Yag Laser System YC-200Nidek Co., Ltd. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −4 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −3 | K022181 | Novus Varia Ophthalmic Laser and Delivery Devices with Accessories | Lumenis, Inc. | 2002 | — |
| −2 | K081704 | Selecta Family of Ophithalmic Laser Systems | Lumenis, Inc. | 2008 | — |
| −1 | K130933 | Solutis | Quantel Medical | 2013 | — |
| 0 (this device) | K140336 | Optimus Fusion: SLT, Yag and Yag/SLT | Quantel Medical | 2014 | — |
| +1 | K192045 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. | 2019 | — |
| +1 | K220430 | Capsulo | Quantel Medical | 2022 | — |
| +2 | 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 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K081704 | Selecta Family of Ophithalmic Laser SystemsSummary page 2…nel: Ophthalmology 3. Predicate Device -Lumenis Family of Selecta Ophthalmic laser Systems, Delivery Device and Accessories :(K08 1704) -Carl Zeiss Meditec VISULAS YAG 1ll (K042139) -Quantel Medical Solutis (K130933) 4. Device Description… | 2008 |
| * | K042139 | Visulas Yag IiiSummary page 2…ice -Lumenis Family of Selecta Ophthalmic laser Systems, Delivery Device and Accessories :(K08 1704) -Carl Zeiss Meditec VISULAS YAG 1ll (K042139) -Quantel Medical Solutis (K130933) 4. Device Description The QUANTEL MEDICAL OPTIMIS FUSION is an ophthalmic s… | 2004 |
| * | K130933 | SolutisSummary page 2…hthalmic laser Systems, Delivery Device and Accessories :(K08 1704) -Carl Zeiss Meditec VISULAS YAG 1ll (K042139) -Quantel Medical Solutis (K130933) 4. Device Description The QUANTEL MEDICAL OPTIMIS FUSION is an ophthalmic surgical laser designed for performing photodi… | 2013 |
| † | K992836 | SL990, SL980, SL950 | 1999 |
What descends from it? (3)
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?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K192045 (Nidek Co., Ltd., 2019) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K081704.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
* OPTIMIS FUSION YAG: photodisruption of ocular tissue using light energy emitted by a Nd: YAG Laser, including discission of posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy.
* OPTIMIS FUSION SLT: Selective laser Trabeculoplasty
* OPTIMIS FUSION YAG/SLT: photodisruption of ocular tissue using light energy emitted by a Nd: YAG Laser, including discission of posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy; and Selective laser Trabeculoplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140336: Optimus Fusion: SLT, Yag and Yag/SLT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140336
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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