Cleared Special

3D OCT-1 Maestro

K170164 · Topcon Corporation · Ophthalmic

Mar 2017

Decision

44d

Days

Class 2

Risk

About This 510(k) Submission

K170164 is an FDA 510(k) clearance for the 3D OCT-1 Maestro, a Tomography, Optical Coherence (Class II — Special Controls, product code OBO), submitted by Topcon Corporation (Tokyo, JP). The FDA issued a Cleared decision on March 3, 2017, 44 days after receiving the submission on January 18, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K170164 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 18, 2017
Decision Date	March 03, 2017
Days to Decision	44 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.