Cleared Traditional

ENHANCED ULTRA VIT PROBE

K093305 · Alcon Research, Ltd. · Ophthalmic
Apr 2010
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K093305 is an FDA 510(k) clearance for the ENHANCED ULTRA VIT PROBE, a Vitrectomy, Instrument Cutter (Class II — Special Controls, product code MLZ), submitted by Alcon Research, Ltd. (Irvine, US). The FDA issued a Cleared decision on April 2, 2010, 162 days after receiving the submission on October 22, 2009. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K093305 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 2009
Decision Date April 02, 2010
Days to Decision 162 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MLZ — Vitrectomy, Instrument Cutter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4150