Cleared Traditional

EIDON FA

K180526 · Centervue S.P.A. · Ophthalmic
Jul 2018
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K180526 is an FDA 510(k) clearance for the EIDON FA, 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 July 16, 2018, 139 days after receiving the submission on February 27, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K180526 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2018
Decision Date July 16, 2018
Days to Decision 139 days
Submission Type Traditional
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