Cleared Traditional

MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM

K073586 · Staar Surgical Co. · Ophthalmic
Mar 2008
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K073586 is an FDA 510(k) clearance for the MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM, a Folders And Injectors, Intraocular Lens (iol) (Class I — General Controls, product code MSS), submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on March 13, 2008, 84 days after receiving the submission on December 20, 2007. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K073586 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2007
Decision Date March 13, 2008
Days to Decision 84 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

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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