Cleared Traditional

IOL INJECTOR SET

K070669 · Medicel AG · Ophthalmic
Nov 2007
Decision
234d
Days
Class 1
Risk

About This 510(k) Submission

K070669 is an FDA 510(k) clearance for the IOL INJECTOR SET, a Lens, Guide, Intraocular (Class I — General Controls, product code KYB), submitted by Medicel AG (Hasbrouck Heights, US). The FDA issued a Cleared decision on November 1, 2007, 234 days after receiving the submission on March 12, 2007. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K070669 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 2007
Decision Date November 01, 2007
Days to Decision 234 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code KYB — Lens, Guide, Intraocular
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4300

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