Cleared Traditional

RE-USEABLE MICROSTAAR INJECTOR, MSI-S (K032412) - FDA 510(k) Clearance

Class I Ophthalmic device.

K032412 · Staar Surgical Co. · Ophthalmic device
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Jun 2004
Decision
310d
Days
Class 1
Risk

K032412 is an FDA 510(k) clearance for the RE-USEABLE MICROSTAAR INJECTOR, MSI-S. Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on June 10, 2004 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Surgical Co. devices

Submission Details

510(k) Number K032412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2003
Decision Date June 10, 2004
Days to Decision 310 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
200d slower than avg
Panel avg: 110d · This submission: 310d
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.