Cleared Traditional

EASY CONTROL MICRO INSERTER, MODEL ON385 (K011498) - FDA 510(k) Clearance

Class I Ophthalmic device.

K011498 · Ophtec USA, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
55d
Days
Class 1
Risk

K011498 is an FDA 510(k) clearance for the EASY CONTROL MICRO INSERTER, MODEL ON385. Classified as Injector, Capsular Tension Ring (product code NCE), Class I - General Controls.

Submitted by Ophtec USA, Inc. (Boca Raton, US). The FDA issued a Cleared decision on July 9, 2001 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - 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 Ophtec USA, Inc. devices

Submission Details

510(k) Number K011498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2001
Decision Date July 09, 2001
Days to Decision 55 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
55d faster than avg
Panel avg: 110d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NCE Injector, Capsular Tension Ring
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
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.