Cleared Traditional

CALLISTO eye

K180858 · Carl Zeiss Meditec, AG · Ophthalmic
Jun 2018
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K180858 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 June 27, 2018, 86 days after receiving the submission on April 2, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K180858 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2018
Decision Date June 27, 2018
Days to Decision 86 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