510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Versavit

K121675510(k) TraditionalCleared Jun 21, 201215-day reviewClass II21 CFR 886.4150Recalls 4

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Synergetics, Inc. · HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered

Cleared on Jun 21, 2012 as substantially equivalent to K911808 (Alcon Laboratories, 1991) after a 15-day review. Its family tree reaches back 1 generation to 1991. 6 later devices descend from it. It has been recalled 4 times.

Decided
Jun 21, 2012
Review
15 days
Class
Class II
Product code
HQE
Recalls
4
Predicates
1

Its longest line of descent runs back 1 generation to K911808 (1991). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2019: 1 descendant cleared2022: 2 descendants cleared2023: 1 descendant cleared2025: 1 descendant clearedK911808 · Gemini Ophthalmic Surgery System · Alcon Laboratories · 1991 · recalled1990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 2 descendants K911808 · Gemini Ophthalmic Surgery System · Alcon Laboratories · 1991 · recalled0
  1. Root · 1 generation backK911808 Gemini Ophthalmic Surgery SystemAlcon Laboratories · 1991 · Recalled
  2. This deviceK121675 VersavitSynergetics, Inc. · 2012
  3. Descendant · cites it directly · 5 of its ownK142877 EVA,anterior machine, EVA, combined machine, EVA combined machine…Dutch Ophthalmic Research Center International BV · 2015
  4. Descendant · 2 generations on · 2 of its ownK190875 EVA, anterior machine, EVA, combined machine, EVA combined machine…D.O.R.C. Dutch Ophthalmic Research Center (International) · 2019 · Recalled
  5. Descendant · 2 generations on · 1 of its ownK213467 EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · Recalled
  6. Descendant · 2 generations on · 1 of its ownK212241 Quatera 700Carl Zeiss Meditec, AG · 2022
  7. Descendant · 3 generations on · 0 of its ownK250501 System SophiThis AG · 2025

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2015: 12019: 12022: 22023: 12025: 1
2015high 2 (2022) · low 0 (2016)2026

Most influential descendants

Showing 5 of 6 · See all
  • K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV · 2015 · cites it directly5descendants
  • K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…D.O.R.C. Dutch Ophthalmic Research Center (International) · 2019 · 2 generations on2descendants
  • K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · 2 generations on1descendant
  • K212241Quatera 700Carl Zeiss Meditec, AG · 2022 · 2 generations on1descendant
  • K250501System SophiThis AG · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K911808Gemini Ophthalmic Surgery SystemAlcon Laboratories19912
0 (this device)K121675VersavitSynergetics, Inc.2012—
+1K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser…Dutch Ophthalmic Research Center International BV2015—
+2K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser…D.O.R.C. Dutch Ophthalmic Research Center (International)20191
+2K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International)20226
+2K212241Quatera 700Carl Zeiss Meditec, AG2022—
+3K250501System SophiThis AG2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201910
202220
202310
202510
FIG. 1 — Lineage of K121675, 1991–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 HQE? 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 HQE device

  1. #1 K212763 UniVit HE, UniVit UHSscore 4.1 · 2 generations · no Class I recall
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K911808Gemini Ophthalmic Surgery System
Summary page 1
…s Aspiration and Culling Instrument Regulatory Class: Class 11 Product Code: HOE FDA Panel: Ophthalmic Predicate Device: Alcon Accurus, K911808 Device Description .The VersaVit is a compact, stand-alone, portable device Summary: with a pneumatic vitrector driv…
Alcon Laboratories19912

Also cleared against K911808: 13 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV20155

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 11, 2016Class IIZ-0120-2017OtherVitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Aug 11, 2016Class IIZ-0119-2017OtherVitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Aug 11, 2016Class IIZ-0121-2017OtherVitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Aug 11, 2016Class IIZ-0122-2017OtherVitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K142877 (Dutch Ophthalmic Research Center International BV, 2015) has gone furthest, with 5 descendants of its own.
  • 13 other devices also cite its predicate K911808.

How does its category compare?

All HQE devices

HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · HQE

1in 2022

2011: 12012: 22014: 12016: 12017: 12022: 1
2007high 2 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQE

Too few HQE 510(k)s in any year since 2007 to give a median.

Recalls per year · HQE

1in 2025

2007: 22010: 112016: 42025: 12026 (partial year): 3
2007high 11 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HQE

339in 2025

2007: 3002008: 652009: 342010: 272011: 212012: 342013: 92014: 92015: 92016: 102017: 592018: 3092019: 412020: 302021: 322022: 462023: 1082024: 1052025: 339
2007high 339 (2025) · low 9 (2013)2025

MAUDE reports naming product code HQE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—2300
20080—065
20090—034
20100—1127
20111—021
20122—034
20130—09
20141—09
20150—09
20161—410
20171—059
20180—0309
20190—041
20200—030
20210—032
20221—046
20230—0108
20240—0105
20250—1339
20260—3—

What is it indicated for?

The Synergetics VersaVit is an ophthalmic microsurgical system that is indicated for posterior segment (i.e. vitreoretinal) ophthalmic surgery. The integrated light source is intended to illuminate the eye during vitreoretinal procedures.

Indications for use as stated in the FDA summary.

Also cleared against K911808

13 other devices cite the same predicate.

  • K121555Centurion Vision SystemAlcon Laboratories, Inc. · 20124 recalls
  • K091441Synergetics Adjustable Gas Pressurized Infusion (Agpi) Tube SetSynergetics, Inc. · 2009
  • K082845Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 2009
  • K063583Alcon Vision SystemAlcon · 200811 recalls
  • K060366The Amo Ophthalmic Surgical SystemAdvanced Medical Optics, Inc. · 20061 recall
  • K050518Reprocessed Phacoemuisification TipsAlliance Medical, Inc. · 2005

More from Synergetics, Inc.

16 FDA decisions under this applicant name. See the company

  • K121426Aynergetics Disposable Spetzler-Malis Standard Bipolar ForcepsSynergetics, Inc. · 201219 recalls
  • K113857Synergetics Directional Endoocular Laser ProbeSynergetics, Inc. · 2012
  • K110924Disposable Spetzler-Malis Dual Irrigating Bipolar ForcepsSynergetics, Inc. · 20113 recalls
  • K091441Synergetics Adjustable Gas Pressurized Infusion (Agpi) Tube SetSynergetics, Inc. · 2009
  • K071482Stryker RF Multi-Lesion Generator, Model 0406-900-000Synergetics, Inc. · 20071 recall

Recent decisions in HQE

The HQE category page

  • K212763UniVit HE, UniVit UHSVisioncare Devices, LLC · 2022
  • K170183Cetus system, Cetus probeA.R.C Laser GmbH · 2017
  • K153168Bi-Blade Vitrectomy CutterMedical Instrument Development Laboratories · 2016
  • K141065Constellation Vision SystemAlcon Research, Ltd. · 20146 recalls
  • K120170Procare Plus Vitrectomy SystemVisioncare Devices, Inc. · 2012

https://510kreport.com/device/K121675 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121675: Versavit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121675

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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