Cleared Traditional

VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430

K101134 · Medicel AG · Ophthalmic
Aug 2010
Decision
109d
Days
Class 1
Risk

About This 510(k) Submission

K101134 is an FDA 510(k) clearance for the VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430, a Folders And Injectors, Intraocular Lens (iol) (Class I — General Controls, product code MSS), submitted by Medicel AG (Monrovia, US). The FDA issued a Cleared decision on August 9, 2010, 109 days after receiving the submission on April 22, 2010. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K101134 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2010
Decision Date August 09, 2010
Days to Decision 109 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MSS — Folders And Injectors, Intraocular Lens (iol)
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4300

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