Cleared Traditional

EPIPHANY INJECTION SYSTEM

K090161 · Staar Surgical Co. · Ophthalmic
Jun 2009
Decision
138d
Days
Class 1
Risk

About This 510(k) Submission

K090161 is an FDA 510(k) clearance for the EPIPHANY INJECTION 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 June 9, 2009, 138 days after receiving the submission on January 22, 2009. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K090161 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2009
Decision Date June 09, 2009
Days to Decision 138 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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