Cleared Traditional

EnFocus 2300, EnFocus 4400

K150722 · Bioptigen, Inc. · Ophthalmic
Dec 2015
Decision
257d
Days
Class 2
Risk

About This 510(k) Submission

K150722 is an FDA 510(k) clearance for the EnFocus 2300, EnFocus 4400, a Ophthalmoscope, Ac-powered (Class II — Special Controls, product code HLI), submitted by Bioptigen, Inc. (Morrisville, US). The FDA issued a Cleared decision on December 2, 2015, 257 days after receiving the submission on March 20, 2015. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K150722 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2015
Decision Date December 02, 2015
Days to Decision 257 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HLI — Ophthalmoscope, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1570

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