Cleared Traditional

EZYPOR

K212741 · Fci (France Chirurgie Instrumentation) Sas · Ophthalmic
Jun 2022
Decision
298d
Days
Class 2
Risk

About This 510(k) Submission

K212741 is an FDA 510(k) clearance for the EZYPOR, a Implant, Eye Sphere (Class II — Special Controls, product code HPZ), submitted by Fci (France Chirurgie Instrumentation) Sas (Paris, FR). The FDA issued a Cleared decision on June 24, 2022, 298 days after receiving the submission on August 30, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3320.

Submission Details

510(k) Number K212741 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2021
Decision Date June 24, 2022
Days to Decision 298 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HPZ — Implant, Eye Sphere
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.3320