Cleared Traditional

K043367 - GLAID OCULAR ELECTROPHYSIOLOGY DEVICE

K043367 is an FDA 510(k) clearance for GLAID OCULAR ELECTROPHYSIOLOGY DEVICE, manufactured by Lace Electronica S.R.L.. The device is a Class 2 Neurology device with product code GWE cleared through the Traditional 510(k) pathway after a 344-day FDA review.

K043367 · Lace Electronica S.R.L. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
344d
Days
Class 2
Risk

K043367 is an FDA 510(k) clearance for the GLAID OCULAR ELECTROPHYSIOLOGY DEVICE. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Lace Electronica S.R.L. (Clearwater, US). The FDA issued a Cleared decision on November 17, 2005 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1890 - the FDA neurology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Lace Electronica S.R.L. devices

FDA 510(k) Submission Details - K043367

510(k) Number K043367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2004
Decision Date November 17, 2005
Days to Decision 344 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
196d slower than avg
Panel avg: 148d · This submission: 344d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWE Device Classification - Class 2, Special Controls

Product Code GWE Stimulator, Photic, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1890
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 Neurology devices follow this clearance model.

Regulatory Peers - GWE Stimulator, Photic, Evoked Response

All 24
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