510(k) · Cleared
ClearedVista Ophthalmics Vitrectomy Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vista Ophthalmics, LLC · MLZ Vitrectomy, Instrument Cutter
Cleared on May 4, 2022 as substantially equivalent to K170520 (Alcon Research, Ltd., 2017) after a 119-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- May 4, 2022
- Review
- 119 days
- Class
- Class II
- Product code
- MLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K933880 (1994). 43 ancestors in all, the oldest K844373 (1985). 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 backK110951 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator…Alcon Research, Ltd. · 2011 · Recalled
- 1 generation backK170520 HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+…Alcon Research, Ltd. · 2017
- This deviceK220030 Vista Ophthalmics Vitrectomy ProbeVista Ophthalmics, LLC · 2022
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 backK110951 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator…Alcon Research, Ltd. · 2011 · Recalled
- 1 generation backK170520 HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+…Alcon Research, Ltd. · 2017
- This deviceK220030 Vista Ophthalmics Vitrectomy ProbeVista Ophthalmics, LLC · 2022
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 | K110951 | 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+… | Alcon Research, Ltd. | 2011 | 1 |
| −1 | K170520 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit… | Alcon Research, Ltd. | 2017 | — |
| 0 (this device) | 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 |
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 MLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K170520 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy…Summary page 4…LZ PREDICATE DEVICE: Alcon Hypervit Vitrectomy Probe Alcon, Inc. K170520 REFERENCE DEVICE: Vision Care ProCare Plus Vision Care Devices,… | 2017 |
| † | K120170 | Procare Plus Vitrectomy System | 2012 |
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 28 years and passes through 8 companies; a new generation was cleared every 3.0 years on median.
- 12 of the 43 ancestors have a recall of any class.
How does its category compare?
All MLZ devicesMLZ Vitrectomy, Instrument Cutter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · MLZ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MLZ
Too few MLZ 510(k)s in any year since 2007 to give a median.
Recalls per year · MLZ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLZ
251in 2025
MAUDE reports naming product code MLZ, 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 | 15 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 13 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 1 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 54 |
| 2021 | 0 | — | 0 | 40 |
| 2022 | 1 | — | 0 | 40 |
| 2023 | 0 | — | 0 | 92 |
| 2024 | 0 | — | 0 | 186 |
| 2025 | 0 | — | 1 | 251 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Vista Ophthalmics vitrectomy probe is intended to be used to remove vitreous and dissect tissue in the eye as follows:
» Vitreous aspiration & cutting
» Membrane cutting & aspiration
* Lens removal
* Dissect tissue in the eye
The Vista Ophthalmics probe is designed as a stand-alone handpiece for use with ophthalmic surgical systems having pneumatically driven vitreoretinal functionality.
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/K220030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220030: Vista Ophthalmics Vitrectomy Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220030
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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