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
Download Printable Device Report (PDF)
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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 110d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Jonathan Kahan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT02376868 Completed Observational Industry-sponsored

Maestro Agreement and Precision Study II

Topcon 3D OCT-1 Maestro Agreement and Precision Study II

101
Patients (actual)
1
Site
Condition studied Normal Healthy Subjects With No Known Ocular Diseases; Glaucomatous Eyes; Eyes With Retinal Diseases
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Charles Reisman, MS
Sponsor Topcon Medical Systems, Inc. (industry)
Started 2015-05-01 → Primary completion 2015-09-01
Primary outcome
Optic Disc Measurements (Optic Disc/Cup Size)
Study completed - no results published. This trial concluded in 2015 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - OBO Tomography, Optical Coherence

All 66
Devices cleared under the same product code (OBO) and FDA review panel - the closest regulatory comparables to K161509.
3D OCT-1 Maestro
K170164 · Topcon Corporation · Mar 2017
EnFocus 2300, EnFocus 4400
K162783 · Bioptigen, Inc. · Dec 2016
PLEX Elite 9000 SS-OCT
K161194 · Carl Zeiss Meditec, Inc. · Oct 2016
Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor
K152205 · Heidelberg Engineering GmbH · May 2016
CIRRUS HD-OCT
K150977 · Carl Zeiss Meditec, Inc. · Sep 2015
RESCAN 700, CALLISTO EYE
K141844 · Carl Zeiss Meditec, AG · Nov 2014