Cleared Traditional

QUATERA 700

K212241 · Carl Zeiss Meditec, AG · Ophthalmic
Apr 2022
Decision
274d
Days
Class 2
Risk

About This 510(k) Submission

K212241 is an FDA 510(k) clearance for the QUATERA 700, 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 April 19, 2022, 274 days after receiving the submission on July 19, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K212241 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2021
Decision Date April 19, 2022
Days to Decision 274 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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