510(k) Report

510(k) · Cleared

Cleared

Edi Veris System

K983983510(k) TraditionalCleared Feb 3, 199986-day reviewClass II21 CFR 886.1630

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

Electro-Diagnostic Imaging, Inc. · HLX Photostimulator, Ac-Powered

Cleared on Feb 3, 1999 as substantially equivalent to K760199 (Lkc Technologies, Inc., 1976) and 2 other predicates after an 86-day review. Its family tree reaches back 1 generation to 1976. 3 later devices descend from it.

Decided
Feb 3, 1999
Review
86 days
Class
Class II
Product code
HLX
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K760199 (1976). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1986: 1 other ancestor2003: 1 descendant cleared2005: 1 descendant cleared2011: 1 descendant clearedK760199 · Electroretinograph · Lkc Technologies, Inc. · 197619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K760199 · Electroretinograph · Lkc Technologies, Inc. · 19760
  1. Root · 1 generation backK760199 ElectroretinographLkc Technologies, Inc. · 1976
  2. This deviceK983983 Edi Veris SystemElectro-Diagnostic Imaging, Inc. · 1999
  3. Descendant · cites it directly · 1 of its ownK043491 EnfanttmDiopsys, Inc. · 2005 · Recalled
  4. Descendant · 2 generations on · 0 of its ownK101763 Diopsys Nova Vep Vision Testing SystemDiopsys, Inc. · 2011
  5. Descendant · cites it directly · 0 of its ownK022304 Accumap Automatic PerimeterObjectivision Pty, Ltd. · 2003

Most influential descendants

Showing 3 of 3 · See all
  • K043491EnfanttmDiopsys, Inc. · 2005 · cites it directly1descendant
  • K101763Diopsys Nova Vep Vision Testing SystemDiopsys, Inc. · 2011 · 2 generations on0descendants
  • K022304Accumap Automatic PerimeterObjectivision Pty, Ltd. · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K760199ElectroretinographLkc Technologies, Inc.1976—
0 (this device)K983983Edi Veris SystemElectro-Diagnostic Imaging, Inc.1999—
+1K043491EnfanttmDiopsys, Inc.20051
+2K101763Diopsys Nova Vep Vision Testing SystemDiopsys, Inc.2011—
+1K022304Accumap Automatic PerimeterObjectivision Pty, Ltd.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
201110
FIG. 1 — Lineage of K983983, 1976–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (3)

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
*K760199Electroretinograph
Summary page 1
…Contact Person: Erich E. Sutter Ph.D. A. Legally Marketed Predicate Device The VERIS System is substantially equivalent to UTAS-E 2000 Visual Eletrodiagnostic System (K760199) manufactured by LKC Technologies, Inc., the Tomey PE400 Portable ERG System (K932571) manufactured by Tomey and the Maculoscope…
Lkc Technologies, Inc.1976—
*K932571Tomey PE-400 Portable Erg & Vep with Optional PS-4
Summary page 1
…S System is substantially equivalent to UTAS-E 2000 Visual Eletrodiagnostic System (K760199) manufactured by LKC Technologies, Inc., the Tomey PE400 Portable ERG System (K932571) manufactured by Tomey and the Maculoscope and The Espion Systems, (K863956) both manufactured by Doran (aka Diagnosys LLC). Thes…
Tomey Corporation USA1995—
*K863956Maculoscope (TM)
Summary page 1
…System (K760199) manufactured by LKC Technologies, Inc., the Tomey PE400 Portable ERG System (K932571) manufactured by Tomey and the Maculoscope and The Espion Systems, (K863956) both manufactured by Doran (aka Diagnosys LLC). These are all hardware and software products. The EDI device is substantially eq…
Doran Instruments, Inc.1986—

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K043491EnfanttmDiopsys, Inc.20051
K022304Accumap Automatic PerimeterObjectivision Pty, Ltd.20030

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K043491 (Diopsys, Inc., 2005) has gone furthest, with 1 descendant of its own.

How does its category compare?

All HLX devices

HLX Photostimulator, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HLX

FDA has decided no HLX device since 2007.

Median 510(k) review, days · HLX

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

Recalls per year · HLX

No recall names HLX since 2007.

Adverse event reports per year · HLX

No MAUDE report names HLX since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The VERIS system is an electhiagnostic device used to generate photic signals and to measure and display the electrical signals generated by the retina and the visual nervous system. It displays digitized electroretinogram (ERG) and visual evoked potential (VEP) signals, power spectra, and topographic maps. These functions are controlled and interpreted by trained medical professionals. The device is intended for use in the diagnosis and management of retinal ischemic diseases, diabetic retinopathy, and central or branch vein occlusion.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Electro-Diagnostic Imaging, Inc.

2 FDA decisions under this applicant name. See the company

  • K003442Modification to Edi Veris SystemElectro-Diagnostic Imaging, Inc. · 2001

Recent decisions in HLX

The HLX category page

  • K003442Modification to Edi Veris SystemElectro-Diagnostic Imaging, Inc. · 2001
  • K925741Clarus Endoscopic Hook KnifeClarus Medical Systems, Inc. · 1993
  • K914393Retina TesterRetina Tester · 1992
  • K914163Scoptopic Sensitivity Test-1[SST-1]Lkc Technologies, Inc. · 1991
  • K873990Iras Eds Interferometric StimulatorRandwal Instrument Co., Inc. · 1988

https://510kreport.com/device/K983983 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983983: Edi Veris System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983983

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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