Cleared Traditional

MICROPERIMETER MP-3

K152729 · Nidek Co., Ltd. · Ophthalmic
Jun 2016
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K152729 is an FDA 510(k) clearance for the MICROPERIMETER MP-3, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Nidek Co., Ltd. (Gamagori, JP). The FDA issued a Cleared decision on June 6, 2016, 258 days after receiving the submission on September 22, 2015. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K152729 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2015
Decision Date June 06, 2016
Days to Decision 258 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HKI — Camera, Ophthalmic, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1120