Cleared Traditional

K983983 - EDI VERIS SYSTEM

K983983 is an FDA 510(k) clearance for EDI VERIS SYSTEM, manufactured by Electro-Diagnostic Imaging, Inc.. The device is a Class 2 Ophthalmic device with product code HLX cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K983983 · Electro-Diagnostic Imaging, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
86d
Days
Class 2
Risk

K983983 is an FDA 510(k) clearance for the 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 February 3, 1999 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Electro-Diagnostic Imaging, Inc. devices

FDA 510(k) Submission Details - K983983

510(k) Number K983983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1998
Decision Date February 03, 1999
Days to Decision 86 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 110d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLX Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HLX Photostimulator, Ac-powered

All 8
Devices cleared under the same product code (HLX) and FDA review panel - the closest regulatory comparables to K983983.
CLARUS ENDOSCOPIC HOOK KNIFE
K925741 · Clarus Medical Systems, Inc. · Aug 1993
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K831231 · Cadwell Laboratories, Inc. · May 1983
CONTRAST SENSITIVITY EQUIPMENT
K830770 · Cadwell Laboratories, Inc. · Apr 1983
5031 BRIGHT FLASH STIMULATOR
K822915 · Life-Tech Intl., Inc. · Dec 1982
5010 VISUSTIM
K822919 · Life-Tech Intl., Inc. · Dec 1982
5011 GANZFELD STIMULATOR
K822922 · Life-Tech Intl., Inc. · Dec 1982