Cleared Traditional

K063304 - LIFE4C

K063304 · Numedis, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K063304

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
305d slower than avg
Panel avg: 110d · This submission: 415d
Pathway characteristics
Predicate-based equivalence.

LYX Device Classification - Class 0,

Product Code LYX Media, Corneal Storage
Device Class -

Regulatory Peers - LYX Media, Corneal Storage

All 20
Devices cleared under the same product code (LYX) and FDA review panel - the closest regulatory comparables to K063304.
Independent Corneal Viewing Chamber (IVC-21)
K211786 · Bausch & Lomb, Incorporated · Dec 2021
Eusol-C
K162013 · Al.Chi.Mi.A. S.R.L · Sep 2016
Cornea Cold
K151061 · Eurobio · Aug 2015
EUSOL-C
K063617 · Al.Chi.Mi.A · Feb 2007
EUSOL-C
K032422 · Al.Chi.Mi.A · Dec 2003
THE CHEN MEDIUM
K954548 · Chen Ophthalmic Laboratories · May 1996
K063304 · LIFE4C
Download PDF FDA Summary Numedis, Inc.