Cleared Traditional

ZYOPTIX XP EPI SEPARATOR SYSTEM

K062465 · Bausch & Lomb, Inc. · Ophthalmic
Sep 2006
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K062465 is an FDA 510(k) clearance for the ZYOPTIX XP EPI SEPARATOR SYSTEM, a Keratome, Ac-powered (Class I — General Controls, product code HNO), submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on September 6, 2006, 13 days after receiving the submission on August 24, 2006. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number K062465 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 2006
Decision Date September 06, 2006
Days to Decision 13 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HNO — Keratome, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4370

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