Cleared Traditional

DRI OCT Triton

K173119 · Topcon Corporation · Ophthalmic

Jan 2018

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K173119 is an FDA 510(k) clearance for the DRI OCT Triton, a Tomography, Optical Coherence (Class II — Special Controls, product code OBO), submitted by Topcon Corporation (Tokyo, JP). The FDA issued a Cleared decision on January 19, 2018, 112 days after receiving the submission on September 29, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K173119 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2017
Decision Date	January 19, 2018
Days to Decision	112 days
Submission Type	Traditional
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.