510(k) Report

510(k) · Cleared

Cleared

Modification to Edi Veris System

K003442510(k) TraditionalCleared May 4, 2001179-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 May 4, 2001 after a 179-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.

Decided
May 4, 2001
Review
179 days
Class
Class II
Product code
HLX
Recalls
None
Predicates
0

7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2021: 1 descendant cleared2009: 1 descendant cleared2022: 2 descendants cleared2012: 1 descendant cleared2011: 1 descendant cleared200020052010201520202025
  1. This deviceK003442 Modification to Edi Veris SystemElectro-Diagnostic Imaging, Inc. · 2001
  2. Descendant · cites it directly · 6 of its ownK023525 Retiscan, RetiportRoland Consult · 2004
  3. Descendant · 2 generations on · 1 of its ownK211643 Vision Monitor - MonpackONEMetrovision · 2021
  4. Descendant · 2 generations on · 1 of its ownK081591 NeucodiaVerisci Corporation · 2009
  5. Descendant · 3 generations on · 0 of its ownK221471 E3 and ProfileDiagnosys, LLC · 2022
  6. Descendant · 2 generations on · 0 of its ownK212936 Vision Monitor- MonCvONEMetrovision · 2022

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2004: 12009: 12011: 12012: 12021: 12022: 2
2004high 2 (2022) · low 0 (2005)2026

Most influential descendants

Showing 5 of 7 · See all
  • K023525Retiscan, RetiportRoland Consult · 2004 · cites it directly6descendants
  • K211643Vision Monitor - MonpackONEMetrovision · 2021 · 2 generations on1descendant
  • K081591NeucodiaVerisci Corporation · 2009 · 2 generations on1descendant
  • K221471E3 and ProfileDiagnosys, LLC · 2022 · 3 generations on0descendants
  • K212936Vision Monitor- MonCvONEMetrovision · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003442Modification to Edi Veris SystemElectro-Diagnostic Imaging, Inc.2001—
+1K023525Retiscan, RetiportRoland Consult2004—
+2K211643Vision Monitor - MonpackONEMetrovision2021—
+2K081591NeucodiaVerisci Corporation2009—
+3K221471E3 and ProfileDiagnosys, LLC2022—
+2K212936Vision Monitor- MonCvONEMetrovision2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200910
201110
201210
202110
202220
FIG. 1 — Lineage of K003442, 2001–2022Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K023525Retiscan, RetiportRoland Consult20046

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?

  • Of its descendants, K023525 (Roland Consult, 2004) has gone furthest, with 6 descendants 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—

More from Electro-Diagnostic Imaging, Inc.

2 FDA decisions under this applicant name. See the company

  • K983983Edi Veris SystemElectro-Diagnostic Imaging, Inc. · 1999

Recent decisions in HLX

The HLX category page

  • K983983Edi Veris SystemElectro-Diagnostic Imaging, Inc. · 1999
  • 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/K003442 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003442: Modification to 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/K003442

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026