510(k) · Cleared
ClearedCapsulo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantel Medical · HQF Laser, Ophthalmic
Cleared on May 12, 2022 as substantially equivalent to K140336 (Quantel Medical, 2014) after an 86-day review. Its family tree reaches back 6 generations to 1989.
- Decided
- May 12, 2022
- Review
- 86 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K894841 (1989). 17 ancestors in all, the oldest K812219 (1981). No later device cites it as a predicate yet.
- Root · 6 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 5 generations backK960971 Oculight GLIriderm Div. · 1996
- 4 generations backK022181 Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2002
- 3 generations backK081704 Selecta Family of Ophithalmic Laser SystemsLumenis, Inc. · 2008
- 2 generations backK130933 SolutisQuantel Medical · 2013
- 1 generation backK140336 Optimus Fusion: SLT, Yag and Yag/SLTQuantel Medical · 2014
- This deviceK220430 CapsuloQuantel Medical · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −5 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −4 | K022181 | Novus Varia Ophthalmic Laser and Delivery Devices with Accessories | Lumenis, Inc. | 2002 | — |
| −3 | K081704 | Selecta Family of Ophithalmic Laser Systems | Lumenis, Inc. | 2008 | — |
| −2 | K130933 | Solutis | Quantel Medical | 2013 | — |
| −1 | K140336 | Optimus Fusion: SLT, Yag and Yag/SLT | Quantel Medical | 2014 | — |
| 0 (this device) | K220430 | Capsulo | Quantel Medical | 2022 | — |
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 |
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 |
|---|---|---|---|
| * | K140336 | Optimus Fusion: SLT, Yag and Yag/SLTSummary page 4…Ophthalmic laser Classification Name Ophthalmic Laser; 21 C.F.R. §886.4390 Class II Product Code: HQF Predicate Device(s) Quantel Medical Optimis Fusion YAG cleared in K140336 Device Description The Yttrium Aluminum Garnet (YAG) ophthalmic laser system produces short pulses of focused infrared light at… | 2014 |
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 33 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 17 ancestors has a recall.
- 1 other device also cites its predicate K140336.
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?
CAPSULO is indicated for photodisruption of ocular tissue using light energy emitted by a Nd:YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220430: Capsulo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220430
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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