Cleared Special

DRSplus

K213705 · Centervue S.P.A. · Ophthalmic
Dec 2021
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K213705 is an FDA 510(k) clearance for the DRSplus, 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 December 21, 2021, 27 days after receiving the submission on November 24, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K213705 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2021
Decision Date December 21, 2021
Days to Decision 27 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