Cleared Traditional

K002920 - MEGAVISION CPX, MEGAVISION FA, MODEL I AND II

K002920 is an FDA 510(k) clearance for MEGAVISION CPX, manufactured by Escalon Medical Corp.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K002920 · Escalon Medical Corp. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
90d
Days
Class 2
Risk

K002920 is an FDA 510(k) clearance for the MEGAVISION CPX, MEGAVISION FA, MODEL I AND II. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Escalon Medical Corp. (New Berlin, US). The FDA issued a Cleared decision on December 18, 2000 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - 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.

FDA 510(k) Submission Details - K002920

510(k) Number K002920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2000
Decision Date December 18, 2000
Days to Decision 90 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
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKI Device Classification - Class 2, Special Controls

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
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 - HKI Camera, Ophthalmic, Ac-powered

All 153
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K002920.
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000
K014274 · Nidek, Inc. · Apr 2002
FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM
K011877 · Carl Zeiss Jena GmbH · Sep 2001
ISCREEN VISION SCREENER
K010315 · Iscreen, LLC · Jun 2001
RETINADX
K003236 · Regulatory Associates, Inc. · Nov 2000
RETCAM II
K001275 · Massie Research Laboratories, Inc. · Jul 2000
EYECAP IMAGING SYSTEM
K000368 · Clement Clarke Intl., Ltd. · May 2000
K002920 · MEGAVISION CPX, MEGAVISION FA, MODEL I AND II
Download PDF FDA Summary Escalon Medical Corp.