Cleared Traditional

K842381 - SLS 3500 LED VISUAL STIMULATOR

K842381 is an FDA 510(k) clearance for SLS 3500 LED VISUAL STIMULATOR, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Neurology device with product code GWE cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K842381 · Nihon Kohden America, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1984
Decision
144d
Days
Class 2
Risk

K842381 is an FDA 510(k) clearance for the SLS 3500 LED VISUAL STIMULATOR. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on November 9, 1984 after a review of 144 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 Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K842381

510(k) Number K842381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1984
Decision Date November 09, 1984
Days to Decision 144 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 148d · This submission: 144d
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
Devices cleared under the same product code (GWE) and FDA review panel - the closest regulatory comparables to K842381.
MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)
K860801 · Cadwell Laboratories, Inc. · Nov 1986
MODIFIED BRAIN ATLAS III
K854362 · Bio-Logic Systems Corp. · Apr 1986
L.E.D. GOGGLES, MODEL 580-LEDGOG
K852533 · Bio-Logic Systems Corp. · Dec 1985
LED STIMULATOR LS-05
K834442 · Teca, Inc. · Aug 1984
BIOLOGIC SYSTEM BL 101
K831047 · Bio-Logic Systems Corp. · May 1983
STIMULATOR MODEL SSS-1101
K791149 · Nihon Kohden America, Inc. · Sep 1979