Cleared Traditional

K935003 - ELECTRIC I/V POLE OR EIVP2

K935003 is an FDA 510(k) clearance for ELECTRIC I/V POLE OR EIVP2, manufactured by Optical Micro Systems, Inc.. The device is a Class 1 Ophthalmic device with product code KYG cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K935003 · Optical Micro Systems, Inc. · Ophthalmic device
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Jan 1994
Decision
98d
Days
Class 1
Risk

K935003 is an FDA 510(k) clearance for the ELECTRIC I/V POLE OR EIVP2. Classified as Device, Irrigation, Ocular Surgery (product code KYG), Class I - General Controls.

Submitted by Optical Micro Systems, Inc. (North Andover, US). The FDA issued a Cleared decision on January 25, 1994 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4360 - 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 Optical Micro Systems, Inc. devices

FDA 510(k) Submission Details - K935003

510(k) Number K935003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1993
Decision Date January 25, 1994
Days to Decision 98 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 110d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

KYG Device Classification - Class 1, General Controls

Product Code KYG Device, Irrigation, Ocular Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4360
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KYG Device, Irrigation, Ocular Surgery

All 22
Devices cleared under the same product code (KYG) and FDA review panel - the closest regulatory comparables to K935003.
DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE
K945171 · Boston Surgical Products, Inc. · Feb 1995
PEREGRINE PIC MINIPULATOR
K940392 · Peregrine Surgical , Ltd. · Aug 1994
I/V POLE
K935226 · Optical Micro Systems, Inc. · Feb 1994
MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE
K925921 · Site Microsurgical Systems, Inc. · Dec 1993
MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS
K922996 · Chiron Vision Corp. · Jul 1992
AQUEOUS PARACENTESIS PIPET
K915808 · Visitec Co. · Mar 1992