Cleared Traditional

Slit Lamp SL-D301

K161972 · Topcon Corporation · Ophthalmic
Dec 2016
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K161972 is an FDA 510(k) clearance for the Slit Lamp SL-D301, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Topcon Corporation (Tokyo, JP). The FDA issued a Cleared decision on December 9, 2016, 144 days after receiving the submission on July 18, 2016. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K161972 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2016
Decision Date December 09, 2016
Days to Decision 144 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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