Cleared Traditional

Retia 2

K180293 · Centervue S.P.A. · Ophthalmic
May 2018
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K180293 is an FDA 510(k) clearance for the Retia 2, 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 May 30, 2018, 118 days after receiving the submission on February 1, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K180293 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2018
Decision Date May 30, 2018
Days to Decision 118 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