510(k) · Cleared
ClearedVisalis V500, Visalis S500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, AG · HQC Unit, Phacofragmentation
Cleared on Jun 15, 2020 as substantially equivalent to K141065 (Alcon Research, Ltd., 2014) after a 193-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- Jun 15, 2020
- Review
- 193 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K933880 (1994). 61 ancestors in all, the oldest K842458 (1984). No later device cites it as a predicate yet.
- Root · 9 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 5 generations between
- 3 generations backK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- 2 generations backK121555 Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · Recalled
- 1 generation backK141065 Constellation Vision SystemAlcon Research, Ltd. · 2014 · Recalled
- This deviceK193376 Visalis V500, Visalis S500Carl Zeiss Meditec, AG · 2020
Show all 9 generations
- Root · 9 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 8 generations backK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
- 7 generations backK964074 Diolite 532Iriderm Div. · 1997
- 6 generations backK982031 Oculight GL with the Dermatology HandpieceIridex Corp · 1998
- 5 generations backK031665 Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003
- 4 generations backK062624 Next Generation LaserAlcon Laboratories · 2007
- 3 generations backK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- 2 generations backK121555 Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · Recalled
- 1 generation backK141065 Constellation Vision SystemAlcon Research, Ltd. · 2014 · Recalled
- This deviceK193376 Visalis V500, Visalis S500Carl Zeiss Meditec, AG · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K933880 | SL Series Surgical Laser Systems | Laserscope | 1994 | — |
| −8 | K954905 | CB Diode/532 Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −7 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| −6 | K982031 | Oculight GL with the Dermatology Handpiece | Iridex Corp | 1998 | — |
| −5 | K031665 | Iris Medical Oculight GL/GLX Laser Systems | Iridex Corp | 2003 | — |
| −4 | K062624 | Next Generation Laser | Alcon Laboratories | 2007 | — |
| −3 | K101285 | Constellation Vision System | Alcon Manufacturing, Ltd. | 2010 | 4 |
| −2 | K121555 | Centurion Vision System | Alcon Laboratories, Inc. | 2012 | 4 |
| −1 | K141065 | Constellation Vision System | Alcon Research, Ltd. | 2014 | 6 |
| 0 (this device) | K193376 | Visalis V500, Visalis S500 | Carl Zeiss Meditec, AG | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 5 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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 HQC? 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 HQC device
- #1 K261264 Stellaris Elite™ vision enhancement system…score 13.4 · 8 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 |
|---|---|---|---|
| * | K141065 | Constellation Vision SystemSummary page 5…tem Trade/Proprietary Name: VISALIS V500 VISALIS S500 Predicate Device ALCON CONSTELLATION ® Vision System Predicate 510(k) K141065 Carl Zeiss Meditec AG Page 1 DEVICE DESCRIPTION (21 CFR §807.92(a)(4… | 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 26 years and passes through 9 companies; a new generation was cleared every 2.1 years on median.
- 19 of the 61 ancestors have a recall of any class.
- 1 other device also cites its predicate K141065.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · HQC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQC
1,799in 2025
MAUDE reports naming product code HQC, 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 | 341 |
| 2008 | 4 | 162 | 1 | 444 |
| 2009 | 5 | 131 | 1 | 540 |
| 2010 | 3 | 142 | 22 | 2,431 |
| 2011 | 5 | 129 | 4 | 1,802 |
| 2012 | 5 | 125 | 1 | 2,277 |
| 2013 | 0 | — | 0 | 2,772 |
| 2014 | 4 | 135 | 1 | 2,740 |
| 2015 | 3 | 124 | 0 | 3,355 |
| 2016 | 1 | — | 0 | 3,374 |
| 2017 | 3 | 214 | 0 | 2,781 |
| 2018 | 0 | — | 2 | 2,416 |
| 2019 | 4 | 126 | 0 | 2,287 |
| 2020 | 4 | 227 | 0 | 1,217 |
| 2021 | 1 | — | 0 | 1,673 |
| 2022 | 4 | 245 | 5 | 1,907 |
| 2023 | 1 | — | 1 | 1,799 |
| 2024 | 5 | 197 | 0 | 2,120 |
| 2025 | 3 | 267 | 1 | 1,799 |
| 2026 | 3 | 115 | 0 | — |
What is it indicated for?
The VISALIS V500 and VISALIS S500 Surgical System is indicated for surgical treatment of the anterior segment of the eye by performing irrigation, irrigation /suction, phacoemulsification of the crystalline lens, anterior vitrectomy and coagulation techniques using bipolar diathermy. The VISALIS V500 is indicated for use in vitreo-retinal surgery such as retinal detachment and other pathologies of the vitreous body and the posterior segment of the human…
Read the full statement (228 words)
The VISALIS V500 and VISALIS S500 Surgical System is indicated for surgical treatment of the anterior segment of the eye by performing irrigation, irrigation /suction, phacoemulsification of the crystalline lens, anterior vitrectomy and coagulation techniques using bipolar diathermy.
The VISALIS V500 is indicated for use in vitreo-retinal surgery such as retinal detachment and other pathologies of the vitreous body and the posterior segment of the human eye.
ACCESSORIES:
ULITE PHACO HANDPIECE
This active re-usable device is an accessory for ZEISS phaco systems. It has been designed to emulsify and aspirate the eye lens during human eye surgery by phacoemulsification technique.
DIATHERMY PROBES
The DIATHERMY PROBES are active re-usable device is an accessory for ZEISS phaco systems. It has been designed to cauterize (stop bleeding) small vessels during human eye surgery on the anterior segment.
ENDODIATHERMY PROBES
This active single use device is an accessory of ZEISS phaco systems with posterior segment functionality. It has been designed to cauterize (stop bleeding) small vessels in the eye bulb and/or on the retina using a high frequency electrical current (generated from the equipment to which it is connected) passed through tissue from one electrode to another.
ENDOILLUMINATION PROBES
This single use device is an accessory of ZEISS phaco systems with posterior segment functionality. It has been designed to internally illuminate the eye bulb transmitting the light emitted by a xenon lamp.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193376 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193376: Visalis V500, Visalis S500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193376
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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