Cleared Traditional

Layer 7-T

K242618 · Precision Neuroscience, Corp. · Neurology
Mar 2025
Decision
208d
Days
Class 2
Risk

About This 510(k) Submission

K242618 is an FDA 510(k) clearance for the Layer 7-T, a Electrode, Cortical (Class II — Special Controls, product code GYC), submitted by Precision Neuroscience, Corp. (Mountain View, US). The FDA issued a Cleared decision on March 30, 2025, 208 days after receiving the submission on September 3, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1310.

Submission Details

510(k) Number K242618 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2024
Decision Date March 30, 2025
Days to Decision 208 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GYC — Electrode, Cortical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1310

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