Cleared Traditional

K151706 - Specular Microscope CEM- 530

K151706 is an FDA 510(k) clearance for Specular Microscope CEM- 530, manufactured by Nidek Co., Ltd.. The device is a Class 2 Ophthalmic device with product code NQE cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K151706 · Nidek Co., Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
267d
Days
Class 2
Risk

K151706 is an FDA 510(k) clearance for the Specular Microscope CEM- 530. Classified as Microscope, Specular (product code NQE), Class II - Special Controls.

Submitted by Nidek Co., Ltd. (Gamagori, JP). The FDA issued a Cleared decision on March 17, 2016 after a review of 267 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 Nidek Co., Ltd. devices

FDA 510(k) Submission Details - K151706

510(k) Number K151706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2015
Decision Date March 17, 2016
Days to Decision 267 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
157d slower than avg
Panel avg: 110d · This submission: 267d
Pathway characteristics
Predicate-based equivalence.

NQE Device Classification - Class 2, Special Controls

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
NCT02276638 Completed Observational Industry-sponsored

Comparative Study of Specular Microscopes for Measurements of Cell Density, Coefficient of Variation and Hexagonality

Comparative Study of the Specular Microscopes for Center Point Method and Corner Point Method for the Measurements of Endothelial Cell Density Measurements, Coefficient of Variation of Endothelial Cell Area and % Hexagonality.

79
Patients (actual)
1
Site
Condition studied Corneal Endothelial Cell Loss
Eligibility All sexes · 18 Years+
Principal investigator Gail Torkildsen, MD
Sponsor Nidek Co. LTD. (industry)
Started 2014-09-01 → Primary completion 2014-10-01
Primary outcome
Center Method Corneal Endothelial Cell Density
View full study on ClinicalTrials.gov

Regulatory Peers - NQE Microscope, Specular

Devices cleared under the same product code (NQE) and FDA review panel - the closest regulatory comparables to K151706.
Konan Specular Microscope XVII
K191558 · Konan Medical, Inc. · Mar 2020
Specular Microscope CEM-530
K173980 · Nidek Co., Ltd. · Mar 2018
EM-4000 Specular Microscope
K171313 · Tomey Corporation · Jan 2018
SP-1PSpecular Microscope
K142417 · Topcon Corporation · May 2015
SPECULAR MICROSCOPE CEM-530
K130565 · Nidek Co., Ltd. · Nov 2013
KONAN SPECULAR MICROSCOPE XIV
K120264 · Konan Medical, Inc. · Apr 2012