Cleared Traditional

SLIT LAMP SL-2000

K163564 · Nidek Co., Ltd. · Ophthalmic
May 2017
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K163564 is an FDA 510(k) clearance for the SLIT LAMP SL-2000, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Nidek Co., Ltd. (Gamagori, JP). The FDA issued a Cleared decision on May 19, 2017, 151 days after receiving the submission on December 19, 2016. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K163564 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2016
Decision Date May 19, 2017
Days to Decision 151 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HJO — Biomicroscope, Slit-lamp, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1850

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