Cleared Special

CALLISTO eye

K232944 · Carl Zeiss Meditec, AG · Ophthalmic
Dec 2023
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K232944 is an FDA 510(k) clearance for the CALLISTO eye, a System, Image Management, Ophthalmic (Class II — Special Controls, product code NFJ), submitted by Carl Zeiss Meditec, AG (Dublic, US). The FDA issued a Cleared decision on December 21, 2023, 92 days after receiving the submission on September 20, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K232944 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2023
Decision Date December 21, 2023
Days to Decision 92 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code NFJ — System, Image Management, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050