Cleared Traditional

NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI

K111493 · Nidek Co., Ltd. · Ophthalmic
Jul 2011
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K111493 is an FDA 510(k) clearance for the NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI, a Photocoagulator And Accessories (Class II — Special Controls, product code HQB), submitted by Nidek Co., Ltd. (Sunnyvale, US). The FDA issued a Cleared decision on July 27, 2011, 57 days after receiving the submission on May 31, 2011. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4690.

Submission Details

510(k) Number K111493 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2011
Decision Date July 27, 2011
Days to Decision 57 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQB — Photocoagulator And Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4690

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