Cleared Traditional

K130565 - SPECULAR MICROSCOPE CEM-530 (FDA 510(k) Clearance)

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

K130565 · Nidek Co., Ltd. · Ophthalmic device
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Nov 2013
Decision
268d
Days
Class 2
Risk

K130565 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. (Andover, US). The FDA issued a Cleared decision on November 27, 2013 after a review of 268 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

Submission Details

510(k) Number K130565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2013
Decision Date November 27, 2013
Days to Decision 268 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
158d slower than avg
Panel avg: 110d · This submission: 268d
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.