Cleared Traditional

CALLISTO eye

K231676 · Carl Zeiss Meditec, AG · Ophthalmic
Aug 2023
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K231676 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 (Jena, DE). The FDA issued a Cleared decision on August 28, 2023, 80 days after receiving the submission on June 9, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K231676 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 2023
Decision Date August 28, 2023
Days to Decision 80 days
Submission Type Traditional
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