Cleared Traditional

3D OCT-1 Maestro

K161509 · Topcon Corporation · Ophthalmic

Jul 2016

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K161509 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 July 28, 2016, 57 days after receiving the submission on June 1, 2016. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K161509 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 2016
Decision Date	July 28, 2016
Days to Decision	57 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.