510(k) · Cleared
ClearedInfinitech Multi-Spot Slit Lamp Laser Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infinitech, Inc. · HQF Laser, Ophthalmic
Cleared on Aug 1, 1997 as substantially equivalent to K844357 (Coherent Medical Group, 1985) after a 65-day review. Its family tree reaches back 1 generation to 1985. 30 later devices descend from it.
- Decided
- Aug 1, 1997
- Review
- 65 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K844357 (1985). 30 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK844357 System 920 Argon/Dye PhotocoagulatorCoherent Medical Group · 1985
- This deviceK971950 Infinitech Multi-Spot Slit Lamp Laser AdapterInfinitech, Inc. · 1997
- Descendant · cites it directly · 29 of its ownK043486 Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005
- Descendant · 2 generations on · 23 of its ownK091666 Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009
- Descendant · 3 generations on · 22 of its ownK092621 Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009
- Descendant · cites it directly · 17 of its ownK081744 Pascal Synthesis Delivery SystemOptimedica Corporation · 2008
- Descendant · 4 generations on · 16 of its ownK100019 Pascal Streamline PhotocoagulatorOptimedica Corporation · 2010 · Recalled
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K043486Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005 · cites it directly29descendants
- K091666Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009 · 2 generations on23descendants
- K092621Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009 · 3 generations on22descendants
- K081744Pascal Synthesis Delivery SystemOptimedica Corporation · 2008 · cites it directly17descendants
- K100019Pascal Streamline PhotocoagulatorOptimedica Corporation · 2010 · 4 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K844357 | System 920 Argon/Dye Photocoagulator | Coherent Medical Group | 1985 | — |
| 0 (this device) | K971950 | Infinitech Multi-Spot Slit Lamp Laser Adapter | Infinitech, Inc. | 1997 | — |
| +1 | K043486 | Pascal Photocoagulator, Product-Pascal-01 | Topcon Medical Laser Systems, Inc. | 2005 | — |
| +2 | K091666 | Pascal Photocoagulator, Pascal-US | Optimedica Corporation | 2009 | — |
| +3 | K092621 | Pascal Streamline Photocoagulator | Topcon Medical Laser Systems, Inc. | 2009 | — |
| +1 | K081744 | Pascal Synthesis Delivery System | Optimedica Corporation | 2008 | — |
| +4 | K100019 | Pascal Streamline Photocoagulator | Optimedica Corporation | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K844357 | System 920 Argon/Dye PhotocoagulatorSummary page 2…pattern improves the repeatability of burn distribution. Predicate Device: The Multi-Spot™ Slit Lamp Adapter is substantially equivalent to the Coherent® System 920AD (K844357), the Alcon®/Biophysic™ Ophthalas® (K number unknown), and Alcon Ophthlas® 532 Laser (K Number Unknown). A device comparison char… | 1985 |
| * | — | Alcon/Biophysic Ophthalas Named without a submission number | |
| * | — | Alcon Ophthlas 532 Laser Named without a submission number |
What descends from it? (30)
See all 302 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?
- Its one ancestor has no recall.
- Of its descendants, K043486 (Topcon Medical Laser Systems, Inc., 2005) has gone furthest, with 29 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 | — |
What is it indicated for?
The Multi-Spot Slit Lamp Laser Adapter has two functional modes
available to the physician:
a single spot mode and a Multi-Spot (4 spot) mode. When the
single spot mode is selected, the preexisting slit lamp laser
apparatus is available for all treatment functions for which
it was designed as a laser photocoagulator.
The multi-spot mode is intended for use with "Green-Only"
(514-532nm) laser energy for panretinal photocoagulation in
the treatment of proliferative retinopathy.
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/K971950 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971950: Infinitech Multi-Spot Slit Lamp Laser Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971950
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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