Cleared Traditional

LIFE4C (K063304) - FDA 510(k) Clearance

K063304 · Numedis, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Dec 2007
Decision
415d
Days
-
Risk

K063304 is an FDA 510(k) clearance for the LIFE4C. Classified as Media, Corneal Storage (product code LYX).

Submitted by Numedis, Inc. (Monson, US). The FDA issued a Cleared decision on December 21, 2007 after a review of 415 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Numedis, Inc. devices

Submission Details

510(k) Number K063304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2006
Decision Date December 21, 2007
Days to Decision 415 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
305d slower than avg
Panel avg: 110d · This submission: 415d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYX Media, Corneal Storage
Device Class -