Cleared Traditional

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

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173980 · Nidek Co., Ltd. · Ophthalmic device
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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
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 110d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.