Cleared Traditional

SL 220

K162684 · Carl Zeiss Meditec, AG · Ophthalmic
May 2017
Decision
247d
Days
Class 2
Risk

About This 510(k) Submission

K162684 is an FDA 510(k) clearance for the SL 220, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Carl Zeiss Meditec, AG (Jena, DE). The FDA issued a Cleared decision on May 31, 2017, 247 days after receiving the submission on September 26, 2016. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K162684 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2016
Decision Date May 31, 2017
Days to Decision 247 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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