Cleared Traditional

K211974 - LED PHOTIC System

K211974 is an FDA 510(k) clearance for LED PHOTIC System, manufactured by Micromed S.P.A.. The device is a Class 2 Neurology device with product code GWE cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K211974 · Micromed S.P.A. · Neurology device
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Sep 2021
Decision
90d
Days
Class 2
Risk

K211974 is an FDA 510(k) clearance for the LED PHOTIC System. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Micromed S.P.A. (Mogliano Veneto, IT). The FDA issued a Cleared decision on September 23, 2021 after a review of 90 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Micromed S.P.A. devices

FDA 510(k) Submission Details - K211974

510(k) Number K211974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2021
Decision Date September 23, 2021
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
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 20
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