Cleared Special

EIDON FA, EIDON, EIDON AF, EIDON UWFL

K211328 · Centervue S.P.A. · Ophthalmic
Aug 2021
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K211328 is an FDA 510(k) clearance for the EIDON FA, EIDON, EIDON AF, EIDON UWFL, a Ophthalmoscope, Laser, Scanning (Class II — Special Controls, product code MYC), submitted by Centervue S.P.A. (Padova, IT). The FDA issued a Cleared decision on August 19, 2021, 108 days after receiving the submission on May 3, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K211328 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 2021
Decision Date August 19, 2021
Days to Decision 108 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MYC — Ophthalmoscope, Laser, Scanning
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1570