Cleared Traditional

DISPOSABLE MICROSTAAR INJECTOR (K940593) - FDA 510(k) Clearance

Class I Ophthalmic device.

K940593 · Staar Sugical · Ophthalmic device
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Sep 1994
Decision
222d
Days
Class 1
Risk

K940593 is an FDA 510(k) clearance for the DISPOSABLE MICROSTAAR INJECTOR. Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by Staar Sugical (Monrovia, US). The FDA issued a Cleared decision on September 19, 1994 after a review of 222 days - an extended review 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: 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 Staar Sugical devices

Submission Details

510(k) Number K940593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1994
Decision Date September 19, 1994
Days to Decision 222 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
112d slower than avg
Panel avg: 110d · This submission: 222d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYB Lens, Guide, Intraocular
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.