Cleared Special

EnFocus 2300, EnFocus 4400

K162783 · Bioptigen, Inc. · Ophthalmic

Dec 2016

Decision

67d

Days

Class 2

Risk

About This 510(k) Submission

K162783 is an FDA 510(k) clearance for the EnFocus 2300, EnFocus 4400, a Tomography, Optical Coherence (Class II — Special Controls, product code OBO), submitted by Bioptigen, Inc. (Morrisville, US). The FDA issued a Cleared decision on December 9, 2016, 67 days after receiving the submission on October 3, 2016. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K162783 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 03, 2016
Decision Date	December 09, 2016
Days to Decision	67 days
Submission Type	Special
Review Panel	Ophthalmic (OP)
Summary	Summary PDF

Device Classification

Product Code	OBO — Tomography, Optical Coherence
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 886.1570
Definition	Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases.