Cleared Traditional

EM-4000 Specular Microscope (K171313) - FDA 510(k) Clearance

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

K171313 · Tomey Corporation · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
260d
Days
Class 2
Risk

K171313 is an FDA 510(k) clearance for the EM-4000 Specular Microscope. Classified as Microscope, Specular (product code NQE), Class II - Special Controls.

Submitted by Tomey Corporation (Nagoya, JP). The FDA issued a Cleared decision on January 19, 2018 after a review of 260 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - 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 Tomey Corporation devices

Submission Details

510(k) Number K171313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2017
Decision Date January 19, 2018
Days to Decision 260 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
150d slower than avg
Panel avg: 110d · This submission: 260d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NQE Microscope, Specular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
Definition Specular Microscopes Are Used For The Microscopic Imaging And Assessment Of The Corneal Endothelial Cell Layer In Vivo Or In Vitro.
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

Ora, Inc.
Ryan Bouchard

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
NCT02977793 Completed Observational Industry-sponsored

Comparative Study of the TOMEY Specular Microscope EM-4000 and the Konan CellChek XL

Comparative Study of the TOMEY Specular Microscope EM-4000 and the Konan CellChek XL for the Measurements of Endothelial Cell Density, Coefficient of Variation of Endothelial Cell Area, % Hexagonality, Central Corneal Thickness

81
Patients (actual)
Condition studied Corneal and Endothelial Cell Measurements
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Tomey Corporation (industry)
Started 2016-10-01 → Primary completion 2017-01-01
Primary outcome
Endothelial cell density measurements
Secondary outcome
Adverse Events
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