Cleared Traditional

LED PHOTIC System

K211974 · Micromed S.P.A. · Neurology
Sep 2021
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K211974 is an FDA 510(k) clearance for the LED PHOTIC System, a Stimulator, Photic, Evoked Response (Class II — Special Controls, product code GWE), submitted by Micromed S.P.A. (Mogliano Veneto, IT). The FDA issued a Cleared decision on September 23, 2021, 90 days after receiving the submission on June 25, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1890.

Submission Details

510(k) Number K211974 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2021
Decision Date September 23, 2021
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWE — Stimulator, Photic, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1890