Cleared Traditional

DRI OCT Triton (K173119) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence.

K173119 · Topcon Corporation · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
112d
Days
Class 2
Risk

K173119 is an FDA 510(k) clearance for the DRI OCT Triton. 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 January 19, 2018 after a review of 112 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Topcon Corporation devices

Submission Details

510(k) Number K173119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 110d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Boston Medtech Advisors, Inc.
Zvi Ladin

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
NCT03067675 Completed Observational Industry-sponsored

Triton Reference Database

Topcon DRI OCT Triton Reference Database Study

500
Patients (actual)
6
Sites
Condition studied Healthy Eyes
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Charles Riesman, MS
Sponsor Topcon Corporation (industry)
Started 2017-03-01 → Primary completion 2017-08-30 → Completed 2017-09-30
Primary outcome
Retinal Thickness
Study completed - no results published. This trial concluded in 2017 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. Individual participant data will not be shared.
View full study on ClinicalTrials.gov