510(k) · Cleared
ClearedNext Generation Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories · HQF Laser, Ophthalmic
Cleared on Nov 5, 2007 as substantially equivalent to K962592 (Alcon Laboratories, 1996) and 2 other predicates after a 426-day review. Its family tree reaches back 5 generations to 1994. 18 later devices descend from it.
- Decided
- Nov 5, 2007
- Review
- 426 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K933880 (1994). 21 ancestors in all, the oldest K883541 (1988). 18 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 4 generations backK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
- 3 generations backK964074 Diolite 532Iriderm Div. · 1997
- 2 generations backK982031 Oculight GL with the Dermatology HandpieceIridex Corp · 1998
- 1 generation backK031665 Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003
- This deviceK062624 Next Generation LaserAlcon Laboratories · 2007
- Descendant · cites it directly · 17 of its ownK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- Descendant · 2 generations on · 6 of its ownK121555 Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · Recalled
- Descendant · cites it directly · 5 of its ownK142877 EVA,anterior machine, EVA, combined machine, EVA combined machine…Dutch Ophthalmic Research Center International BV · 2015
- Descendant · 3 generations on · 3 of its ownK161794 CENTURION Vision System (Active SentryTM)Alcon Research, Ltd. · 2017
- Descendant · cites it directly · 3 of its ownK110951 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator…Alcon Research, Ltd. · 2011 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K101285Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · cites it directly17descendants
- K121555Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · 2 generations on6descendants
- K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV · 2015 · cites it directly5descendants
- K161794CENTURION Vision System (Active SentryTM)Alcon Research, Ltd. · 2017 · 3 generations on3descendants
- K11095127+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved…Alcon Research, Ltd. · 2011 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933880 | SL Series Surgical Laser Systems | Laserscope | 1994 | — |
| −4 | K954905 | CB Diode/532 Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −3 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| −2 | K982031 | Oculight GL with the Dermatology Handpiece | Iridex Corp | 1998 | — |
| −1 | K031665 | Iris Medical Oculight GL/GLX Laser Systems | Iridex Corp | 2003 | — |
| 0 (this device) | K062624 | Next Generation Laser | Alcon Laboratories | 2007 | — |
| +1 | K101285 | Constellation Vision System | Alcon Manufacturing, Ltd. | 2010 | 4 |
| +2 | K121555 | Centurion Vision System | Alcon Laboratories, Inc. | 2012 | 4 |
| +1 | K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser… | Dutch Ophthalmic Research Center International BV | 2015 | — |
| +3 | K161794 | CENTURION Vision System (Active SentryTM) | Alcon Research, Ltd. | 2017 | — |
| +1 | K110951 | 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+… | Alcon Research, Ltd. | 2011 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 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 |
|---|---|---|---|
| * | K962592 | Ophthalas 532 Solid State Photocoagulator, or Equivalent Laser SystemsSummary page 1…almic Laser or, Frequency Doubled (532nm) Laser Classification Name: Laser, Ophthalmic (21 CFR 886.4390) 5.1. Predicate Devices 510(k) Number Device K962592 Alcon Eyelite® K04 1598 LaserexTM Solitaire K031665 Iris Medical Oculight TM 5.2. De… | 1996 |
| * | K041598 | Laserex, Model LP4532Summary page 1…nm) Laser Classification Name: Laser, Ophthalmic (21 CFR 886.4390) 5.1. Predicate Devices 510(k) Number Device K962592 Alcon Eyelite® K04 1598 LaserexTM Solitaire K031665 Iris Medical Oculight TM 5.2. Device Description The NGL Ophthalmic La… | 2004 |
| * | K031665 | Iris Medical Oculight GL/GLX Laser SystemsSummary page 1…, Ophthalmic (21 CFR 886.4390) 5.1. Predicate Devices 510(k) Number Device K962592 Alcon Eyelite® K04 1598 LaserexTM Solitaire K031665 Iris Medical Oculight TM 5.2. Device Description The NGL Ophthalmic Laser, like its predicate device Alcon Ophth… | 2003 |
What descends from it? (18)
See all 184 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101285 | Constellation Vision System | 2010 | 17 |
| K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC… | 2015 | 5 |
| K110951 | 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved… | 2011 | 3 |
| K233876 | Unity VCS (8065000296); Unity CS (8065000297) | 2024 | 0 |
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 13 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 21 ancestors have a recall of any class.
- Of its descendants, K101285 (Alcon Manufacturing, Ltd., 2010) has gone furthest, with 17 descendants of its own.
- 3 other devices also cite its predicate K962592.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The NGL is indicated for use in photocoagulation of both anterior and posterior segments of the eye including: * Retinal Photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: - Proliferative and nonproliferative retinopathy (including diabetic); - Choroidal neovascularization secondary to age-related macular degeneration; - Retinal tears and…
Read the full statement (128 words)
The NGL is indicated for use in photocoagulation of both anterior and posterior segments of
the eye including:
* Retinal Photocoagulation, panretinal photocoagulation and intravitreal
endophotocoagulation of vascular and structural abnormalities of the retina and
choroid including:
- Proliferative and nonproliferative retinopathy (including diabetic);
- Choroidal neovascularization secondary to age-related macular degeneration;
- Retinal tears and detachments;
- Macular Edema;
- Retinopathy of prematurity;
- Choroidal neovascularization;
- Leaking microaneurysms.
* Iridotomy/Iridectomy for treatment of Chronic/Primary Open Angle Glaucoma
(COAG,POAG), Acute Angle Closure Glaucoma (AACG), and Refractory Glaucoma.
* Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma
(COAG,POAG) and Refractory Glaucoma.
• And other laser treatments including:
- Internal sclerostomy;
- Lattice degeneration;
- Central and Branch Retinal Vein Occlusion;
- Suturelysis;
- Vascular and pigmented skin lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062624: Next Generation Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062624
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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