Cleared Traditional

Visalis V500, Visalis S500

K193376 · Carl Zeiss Meditec, AG · Ophthalmic
Jun 2020
Decision
193d
Days
Class 2
Risk

About This 510(k) Submission

K193376 is an FDA 510(k) clearance for the Visalis V500, Visalis S500, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Carl Zeiss Meditec, AG (Jena, DE). The FDA issued a Cleared decision on June 15, 2020, 193 days after receiving the submission on December 5, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K193376 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2019
Decision Date June 15, 2020
Days to Decision 193 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQC — Unit, Phacofragmentation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4670

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