Cleared Traditional

Excelsior

K220929 · Merit Cro, Inc. · Ophthalmic
Oct 2022
Decision
214d
Days
Class 2
Risk

About This 510(k) Submission

K220929 is an FDA 510(k) clearance for the Excelsior, a System, Image Management, Ophthalmic (Class II — Special Controls, product code NFJ), submitted by Merit Cro, Inc. (Madison, US). The FDA issued a Cleared decision on October 31, 2022, 214 days after receiving the submission on March 31, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K220929 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2022
Decision Date October 31, 2022
Days to Decision 214 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