510(k) · Cleared
Recalled · Class II · 202527+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved Entry System, 27+ Infusion Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Research, Ltd. · HQB Photocoagulator And Accessories
Cleared on Oct 17, 2011 as substantially equivalent to K093305 (Alcon Research, Ltd., 2010) and 3 other predicates after a 196-day review. Its family tree reaches back 7 generations to 1994. 3 later devices descend from it. It has been recalled once.
- Decided
- Oct 17, 2011
- Review
- 196 days
- Class
- Class II
- Product code
- HQB
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 7 generations to K933880 (1994). 41 ancestors in all, the oldest K844373 (1985). 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 6 generations backK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
- 5 generations backK964074 Diolite 532Iriderm Div. · 1997
- 4 generations backK982031 Oculight GL with the Dermatology HandpieceIridex Corp · 1998
- 3 generations backK031665 Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003
- 2 generations backK062624 Next Generation LaserAlcon Laboratories · 2007
- 1 generation backK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- This deviceK110951 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator…Alcon Research, Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK170520 HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+…Alcon Research, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK242184 Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle…Alcon Laboratories, Inc. · 2024 · Recalled
- Descendant · 2 generations on · 0 of its ownK220030 Vista Ophthalmics Vitrectomy ProbeVista Ophthalmics, LLC · 2022
Most influential descendants
Showing 3 of 3 · See all- K170520HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy…Alcon Research, Ltd. · 2017 · cites it directly1descendant
- K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator…Alcon Laboratories, Inc. · 2024 · cites it directly0descendants
- K220030Vista Ophthalmics Vitrectomy ProbeVista Ophthalmics, LLC · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K933880 | SL Series Surgical Laser Systems | Laserscope | 1994 | — |
| −6 | K954905 | CB Diode/532 Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −5 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| −4 | K982031 | Oculight GL with the Dermatology Handpiece | Iridex Corp | 1998 | — |
| −3 | K031665 | Iris Medical Oculight GL/GLX Laser Systems | Iridex Corp | 2003 | — |
| −2 | K062624 | Next Generation Laser | Alcon Laboratories | 2007 | — |
| −1 | K101285 | Constellation Vision System | Alcon Manufacturing, Ltd. | 2010 | 4 |
| 0 (this device) | K110951 | 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+… | Alcon Research, Ltd. | 2011 | — |
| +1 | K170520 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit… | Alcon Research, Ltd. | 2017 | — |
| +1 | K242184 | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator… | Alcon Laboratories, Inc. | 2024 | 2 |
| +2 | K220030 | Vista Ophthalmics Vitrectomy Probe | Vista Ophthalmics, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 HQB? 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 HQB device
- #1 K220263 Vortex Surgical Laser Probes, Vortex Surgical…score 3.8 · 6 generations · no Class I recall
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K093305 | Enhanced Ultra Vit ProbeSummary page 1…Code W~k Cleared 27+ UltraVite 886.4150 Vitreous aspiration and 11 HOE K093305 04/02/10 Probe cutting instrument1 27+ Flex-Tip 886.4390 Ophthalmic laser… | 2010 |
| * | K062624 | Next Generation LaserSummary page 1…E K093305 04/02/10 Probe cutting instrument1 27+ Flex-Tip 886.4390 Ophthalmic laser 11 HQB K062624 11/05/07 Laser Probe 27+ 876.1500 Endoscope and 11 MPA K063583 05/09/08… | 2007 |
| * | K063583 | Alcon Vision SystemSummary page 1…Ophthalmic laser 11 HQB K062624 11/05/07 Laser Probe 27+ 876.1500 Endoscope and 11 MPA K063583 05/09/08 Endoilluminator accessories K101285 11/12/10 Probe 27… | 2008 |
| * | K101285 | Constellation Vision SystemSummary page 1…876.1500 Endoscope and 11 MPA K063583 05/09/08 Endoilluminator accessories K101285 11/12/10 Probe 27+ Valved Entry 886.4350 Manual ophthalmic I NGY n/a System… | 2010 |
| * | — | 25Ga Valved Entry System Named without a submission number | |
| * | — | 25Ga Infusion Cannula Named without a submission number |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 15, 2025 | Class II | Z-0581-2026 | Component change control | XXX |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 11 of the 41 ancestors have a recall of any class.
- Of its descendants, K170520 (Alcon Research, Ltd., 2017) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K093305.
How does its category compare?
All HQB devicesHQB Photocoagulator And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HQB
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HQB
221in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQB
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQB
7in 2025
MAUDE reports naming product code HQB, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 3 | 57 | 0 | 3 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 3 | 221 | 28 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 2 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 2 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The 27+ Retina Instrument Set instruments, along with the Constellation Vision System or Next Generation Laser System, are intended for the following uses: 27+ UltraVit Probe * Vitreous aspiration & cutting. * Membrane cutting & aspiration. * Lens removal. * Dissect tissue in the eye. (The 27+ UltraVit Probe is intended to be used with the Alcon Constellation Vision System.) 27+ Flex-Tip Laser Probe * Retinal photocoagulation, panretinal photocoagulation…
Read the full statement (245 words)
The 27+ Retina Instrument Set instruments, along with the Constellation Vision System or Next Generation Laser System, are intended for the following uses:
27+ UltraVit Probe
* Vitreous aspiration & cutting.
* Membrane cutting & aspiration.
* Lens removal.
* Dissect tissue in the eye.
(The 27+ UltraVit Probe is intended to be used with the Alcon Constellation Vision System.)
27+ Flex-Tip Laser Probe
* Retinal photocoagulation, panretinal photocoagulation and intravitreal photocoagulation of vascular and structural abnormalities of the retina and choroid including:
o Proliferative and nonproliferative retinopathy (including diabetic);
o Choroidal neovascularization secondary to age-related macular degeneration;
o Retinal tears and detachments;
o Macular edema;
o Retinopathy of prematurity;
o Choroidal neovascularization;
o Leaking microaneurysms.
* Iridotomy/iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and Refractory Glaucoma.
* Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and refractory Glaucoma.
* And other laser treatments including:
o Internal sclerostomy;
o Lattice degeneration;
o Central and Branch Retinal Vein Occlusion;
o Suturelysis;
o Vascular and pigmented skin lesions.
(The 27+ Flex-Tip Probe is intended to be used with 532 nm laser systems such as the Alcon Constellation Vision System, or the Alcon PurePoint Laser System.)
27+ Endoilluminator Probe
* Endoillumination
(The 27+ Endoilluminator Probe is intended to be used with the Alcon Constellation Vision System)
27+ Valved Entry System
* Scleral incision
* Cannulae for posterior segment instrument access
* Venting (of valved cannulae)
27+ Infusion Cannula
* Posterior segment infusion (liquid or gas)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110951 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110951: 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved Entry System, 27+ Infusion Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110951
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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