Cleared Traditional

RE-USEABLE MICROSTAAR INJECTOR, MSI-S

K032412 · Staar Surgical Co. · Ophthalmic
Jun 2004
Decision
310d
Days
Class 1
Risk

About This 510(k) Submission

K032412 is an FDA 510(k) clearance for the RE-USEABLE MICROSTAAR INJECTOR, MSI-S, a Lens, Guide, Intraocular (Class I — General Controls, product code KYB), submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on June 10, 2004, 310 days after receiving the submission on August 5, 2003. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K032412 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2003
Decision Date June 10, 2004
Days to Decision 310 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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