510(k) · Cleared
ClearedModel 900S Intraocular Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Inc. · HQF Laser, Ophthalmic
Cleared on Nov 16, 1981 after a 102-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 297 later devices descend from it.
- Decided
- Nov 16, 1981
- Review
- 102 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 0
297 later devices descend from it, 1 citing it directly.
- This deviceK812219 Model 900S Intraocular ProbeLumenis, Inc. · 1981
- Descendant · cites it directly · 296 of its ownK991258 Novus Verdi Delivery SystemsLumenis, Inc. · 1999
- Descendant · 2 generations on · 225 of its ownK050738 FT Fiber Optic Delivery SystemsFibertech GmbH · 2005 · Recalled
- Descendant · 3 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 4 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- Descendant · 5 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
Showing 5 of 297 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 297 · See all- K991258Novus Verdi Delivery SystemsLumenis, Inc. · 1999 · cites it directly296descendants
- K050738FT Fiber Optic Delivery SystemsFibertech GmbH · 2005 · 2 generations on225descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 3 generations on221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 4 generations on202descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 5 generations on192descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K812219 | Model 900S Intraocular Probe | Lumenis, Inc. | 1981 | — |
| +1 | K991258 | Novus Verdi Delivery Systems | Lumenis, Inc. | 1999 | — |
| +2 | K050738 | FT Fiber Optic Delivery Systems | Fibertech GmbH | 2005 | 5 |
| +3 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +4 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +5 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 11 | 0 |
| 2009 | 10 | 0 |
| 2010 | 11 | 0 |
| 2011 | 11 | 0 |
| 2012 | 7 | 0 |
| 2013 | 13 | 0 |
| 2014 | 12 | 0 |
| 2015 | 13 | 0 |
| 2016 | 14 | 0 |
| 2017 | 11 | 0 |
| 2018 | 12 | 0 |
| 2019 | 12 | 0 |
| 2020 | 17 | 0 |
| 2021 | 10 | 0 |
| 2022 | 27 | 0 |
| 2023 | 15 | 0 |
| 2024 | 25 | 0 |
| 2025 | 29 | 0 |
| 2026 | 17 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (297)
See all 2971 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991258 | Novus Verdi Delivery Systems | 1999 | 296 |
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?
- Of its descendants, K991258 (Lumenis, Inc., 1999) has gone furthest, with 296 descendants of its own.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K812219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K812219: Model 900S Intraocular Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K812219
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026