Cleared Traditional

K161509 - 3D OCT-1 Maestro

K161509 is an FDA 510(k) clearance for 3D OCT-1 Maestro, manufactured by Topcon Corporation. The device is a Class 2 Ophthalmic device with product code OBO cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K161509 · Topcon Corporation · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Jul 2016
Decision
57d
Days
Class 2
Risk

K161509 is an FDA 510(k) clearance for the 3D OCT-1 Maestro. Classified as Tomography, Optical Coherence (product code OBO), Class II - Special Controls.

Submitted by Topcon Corporation (Tokyo, JP). The FDA issued a Cleared decision on July 28, 2016 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Topcon Corporation devices

FDA 510(k) Submission Details - K161509

510(k) Number K161509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 110d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OBO Device Classification - Class 2, Special Controls

Product Code OBO Tomography, Optical Coherence
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - OBO Tomography, Optical Coherence

All 42
Devices cleared under the same product code (OBO) and FDA review panel - the closest regulatory comparables to K161509.
P200TE
K173707 · Optos Plc. · Feb 2018
DRI OCT Triton
K173119 · Topcon Corporation · Jan 2018
PLEX Elite 9000 SS-OCT
K161194 · Carl Zeiss Meditec, Inc. · Oct 2016
CIRRUS HD-OCT
K150977 · Carl Zeiss Meditec, Inc. · Sep 2015
RESCAN 700, CALLISTO EYE
K141844 · Carl Zeiss Meditec, AG · Nov 2014
CIRRUS PHOTO
K133217 · Carl Zeiss Meditec, AG · Mar 2014