Cleared Traditional

EUSOL-C (K032422) - FDA 510(k) Clearance

K032422 · Al.Chi.Mi.A · Ophthalmic device
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Dec 2003
Decision
132d
Days
-
Risk

K032422 is an FDA 510(k) clearance for the EUSOL-C. Classified as Media, Corneal Storage (product code LYX).

Submitted by Al.Chi.Mi.A (Hasbrouck Heights, US). The FDA issued a Cleared decision on December 15, 2003 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel. 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.

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Submission Details

510(k) Number K032422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2003
Decision Date December 15, 2003
Days to Decision 132 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
22d slower than avg
Panel avg: 110d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYX Media, Corneal Storage
Device Class -