Cleared Traditional

iExaminer System with Panoptic Plus

K223381 · Welch Allyn, Inc. · Ophthalmic
Mar 2023
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K223381 is an FDA 510(k) clearance for the iExaminer System with Panoptic Plus, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on March 15, 2023, 128 days after receiving the submission on November 7, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K223381 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2022
Decision Date March 15, 2023
Days to Decision 128 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HKI — Camera, Ophthalmic, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1120