Cleared Traditional

QUATERA 700

K230858 · Carl Zeiss Meditec, AG · Ophthalmic
Jul 2023
Decision
124d
Days
Class 2
Risk

About This 510(k) Submission

K230858 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 July 31, 2023, 124 days after receiving the submission on March 29, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K230858 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2023
Decision Date July 31, 2023
Days to Decision 124 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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