510(k) Report

510(k) · Cleared

Cleared

Synergetics Synerlight Fiber Optic Lightsource

K032598510(k) TraditionalCleared Nov 24, 200391-day reviewClass II21 CFR 876.1500

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

Synergetics, Inc. · MPA Endoilluminator

Cleared on Nov 24, 2003 as substantially equivalent to K964005 (Synergetics, Inc., 1997) after a 91-day review. Its family tree reaches back 1 generation to 1997. 38 later devices descend from it.

Decided
Nov 24, 2003
Review
91 days
Class
Class II
Product code
MPA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K964005 (1997). 38 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2015: 5 descendants cleared2009: 2 descendants cleared2010: 2 descendants cleared2014: 2 descendants cleared2012: 4 descendants cleared2011: 4 descendants cleared2017: 5 descendants cleared2019: 2 descendants cleared2024: 3 descendants cleared2020: 2 descendants cleared2022: 3 descendants cleared2013: 1 descendant cleared2023: 1 descendant cleared2025: 1 descendant clearedK964005 · Synergetics Synerlight Fiber Optic Lightsource · Synergetics, Inc. · 19971995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 7 descendants3 generations forward: 10 descendants4 generations forward: 8 descendants5 generations forward: 6 descendants6 generations forward: 2 descendants7 generations forward: 3 descendants K964005 · Synergetics Synerlight Fiber Optic Lightsource · Synergetics, Inc. · 19970+5
  1. Root · 1 generation backK964005 Synergetics Synerlight Fiber Optic LightsourceSynergetics, Inc. · 1997
  2. This deviceK032598 Synergetics Synerlight Fiber Optic LightsourceSynergetics, Inc. · 2003
  3. Descendant · cites it directly · 36 of its ownK063583 Alcon Vision SystemAlcon · 2008 · Recalled
  4. Descendant · 2 generations on · 22 of its ownK082845 Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 2009
  5. Descendant · 2 generations on · 20 of its ownK091777 Alcon UltrachopperAlcon Research, Ltd. · 2009
  6. Descendant · 2 generations on · 18 of its ownK093305 Enhanced Ultra Vit ProbeAlcon Research, Ltd. · 2010
  7. Descendant · 2 generations on · 17 of its ownK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2008: 12009: 22010: 22011: 42012: 42013: 12014: 22015: 52017: 52019: 22020: 22022: 32023: 12024: 32025: 1
2008high 5 (2015) · low 0 (2016)2026

Most influential descendants

Showing 5 of 38 · See all
  • K063583Alcon Vision SystemAlcon · 2008 · cites it directly36descendants
  • K082845Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 2009 · 2 generations on22descendants
  • K091777Alcon UltrachopperAlcon Research, Ltd. · 2009 · 2 generations on20descendants
  • K093305Enhanced Ultra Vit ProbeAlcon Research, Ltd. · 2010 · 2 generations on18descendants
  • K101285Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · 2 generations on17descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K964005Synergetics Synerlight Fiber Optic LightsourceSynergetics, Inc.1997—
0 (this device)K032598Synergetics Synerlight Fiber Optic LightsourceSynergetics, Inc.2003—
+1K063583Alcon Vision SystemAlcon200811
+2K082845Infiniti Vision System with Ozil IPAlcon Research, Ltd.2009—
+2K091777Alcon UltrachopperAlcon Research, Ltd.2009—
+2K093305Enhanced Ultra Vit ProbeAlcon Research, Ltd.2010—
+2K101285Constellation Vision SystemAlcon Manufacturing, Ltd.20104

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200920
201020
201140
201240
201310
201420
201550
201750
201920
202020
202230
202310
202430
202510
FIG. 1 — Lineage of K032598, 1997–2025Source: 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 MPA? 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 MPA device

  1. #1 K253468 Nova Eye iTrack™ 250A Canaloplasty…score 12.7 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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
*K964005Synergetics Synerlight Fiber Optic Lightsource
Summary page 1
…Trade Name: Synergetics Synerlight Fiberoptic Lightsource Common Name: Ophthalmic Fiberoptic Lightsource 1’1-edica te Device: K964005 L)escription/Intended Use: The intended use of the device is to illuminate the eye during anterio…
Synergetics, Inc.1997—

Also cleared against K964005: 1 other device →

What descends from it? (38)

See all 38

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K063583Alcon Vision SystemAlcon200836
K143123Synergetics PHOTON EXSynergetics20150

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?

  • Its one ancestor has no recall.
  • Of its descendants, K063583 (Alcon, 2008) has gone furthest, with 36 descendants of its own.
  • 1 other device also cites its predicate K964005.

How does its category compare?

All MPA devices

MPA Endoilluminator: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MPA

2in 2024

2008: 12015: 22021: 12023: 12024: 22026 (partial year): 1
2007high 2 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MPA

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

Recalls per year · MPA

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

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

Adverse event reports per year · MPA

11in 2025

2007: 42008: 102009: 42010: 392011: 322012: 352013: 192014: 102015: 42016: 22017: 22018: 42022: 32023: 82024: 622025: 11
2007high 62 (2024) · low 0 (2019)2025

MAUDE reports naming product code MPA, 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—04
20081—010
20090—04
20100—039
20110—032
20120—035
20130—019
20140—010
20152—04
20160—02
20170—02
20180—04
20190—00
20200—00
20211—00
20220—03
20231—08
20242—062
20250—111
20261—0—

What is it indicated for?

The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery and to provide photocoagulation when used with the appropriate commercially available laser light source and probe.

Indications for use as stated in the FDA summary.

Also cleared against K964005

1 other device cites the same predicate.

  • K062259Iscience Surgical Fiberoptic Illuminator, Model FI - 100Iscience Surgical · 2006

More from Synergetics, Inc.

16 FDA decisions under this applicant name. See the company

  • K121426Aynergetics Disposable Spetzler-Malis Standard Bipolar ForcepsSynergetics, Inc. · 201219 recalls
  • K121675VersavitSynergetics, Inc. · 20124 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

Recent decisions in MPA

The MPA category page

  • K253468Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)Nova Eye, Inc. · 2026
  • K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS…Alcon Laboratories, Inc. · 20242 recalls
  • K233653Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga…Peregrine Surgical, LLC · 2024
  • K221872ITrack Advance Canaloplasty Microcatheter with Advanced Delivery SystemNova Eye Inc. (Business Name Nova Eye Medical) · 2023
  • K202670Nam illumination probe with chopperOculight, Ltd. · 2021

https://510kreport.com/device/K032598 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032598: Synergetics Synerlight Fiber Optic Lightsource.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032598

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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