Cleared Traditional

MODIFICATION TO EDI VERIS SYSTEM (K003442) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K003442 · Electro-Diagnostic Imaging, Inc. · Ophthalmic device
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May 2001
Decision
179d
Days
Class 2
Risk

K003442 is an FDA 510(k) clearance for the MODIFICATION TO EDI VERIS SYSTEM. Classified as Photostimulator, Ac-powered (product code HLX), Class II - Special Controls.

Submitted by Electro-Diagnostic Imaging, Inc. (Los Altos, US). The FDA issued a Cleared decision on May 4, 2001 after a review of 179 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1630 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Electro-Diagnostic Imaging, Inc. devices

Submission Details

510(k) Number K003442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2000
Decision Date May 04, 2001
Days to Decision 179 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 110d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HLX Photostimulator, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.