Cleared Traditional

FORUM

K213527 · Carl Zeiss Meditec, AG · Ophthalmic
Aug 2022
Decision
284d
Days
Class 2
Risk

About This 510(k) Submission

K213527 is an FDA 510(k) clearance for the FORUM, 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 15, 2022, 284 days after receiving the submission on November 4, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K213527 FDA.gov
FDA Decision Cleared SESE
Date Received November 04, 2021
Decision Date August 15, 2022
Days to Decision 284 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