Cleared Traditional

Specular Microscope CEM-530 (K173980) - FDA 510(k) Clearance

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

K173980 · Nidek Co., Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
75d
Days
Class 2
Risk

K173980 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 14, 2018 after a review of 75 days - a notably fast clearance 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: 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 Nidek Co., Ltd. devices

Submission Details

510(k) Number K173980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2017
Decision Date March 14, 2018
Days to Decision 75 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
35d faster than avg
Panel avg: 110d · This submission: 75d
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
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