Cleared Traditional

E3 and Profile

K221471 · Diagnosys, LLC · Ophthalmic
Nov 2022
Decision
186d
Days
Class 2
Risk

About This 510(k) Submission

K221471 is an FDA 510(k) clearance for the E3 and Profile, a Stimulator, Photic, Evoked Response (Class II — Special Controls, product code GWE), submitted by Diagnosys, LLC (Lowell, US). The FDA issued a Cleared decision on November 22, 2022, 186 days after receiving the submission on May 20, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 882.1890.

Submission Details

510(k) Number K221471 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2022
Decision Date November 22, 2022
Days to Decision 186 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

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