Cleared Traditional

K991903 - EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)

K991903 is an FDA 510(k) clearance for EXCEL PHOTIC STIMULATOR, manufactured by Excel Tech. , Ltd.. The device is a Class 2 Neurology device with product code GWE cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K991903 · Excel Tech. , Ltd. · Neurology device
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Aug 1999
Decision
61d
Days
Class 2
Risk

K991903 is an FDA 510(k) clearance for the EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1). Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Excel Tech. , Ltd. (Oakville,Ontario, CA). The FDA issued a Cleared decision on August 4, 1999 after a review of 61 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Excel Tech. , Ltd. devices

FDA 510(k) Submission Details - K991903

510(k) Number K991903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1999
Decision Date August 04, 1999
Days to Decision 61 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 148d · This submission: 61d
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 28
Devices cleared under the same product code (GWE) and FDA review panel - the closest regulatory comparables to K991903.
ENFANTTM
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KILOWIN
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K880593 · Teca, Inc. · Apr 1988
PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL
K874136 · Bio-Logic Systems Corp. · Mar 1988