Cleared Traditional

K871932 - MODEL 5050 SURGILASER FOR UROLOGY USE (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K871932 · Lasermatic, Inc. · Gastroenterology & Urology device
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Mar 1988
Decision
311d
Days
Class 2
Risk

K871932 is an FDA 510(k) clearance for the MODEL 5050 SURGILASER FOR UROLOGY USE. Classified as Laser For Gastro-urology Use (product code LNK), Class II - Special Controls.

Submitted by Lasermatic, Inc. (Dallas, US). The FDA issued a Cleared decision on March 25, 1988 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.4810 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Lasermatic, Inc. devices

Submission Details

510(k) Number K871932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1987
Decision Date March 25, 1988
Days to Decision 311 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 130d · This submission: 311d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNK Laser For Gastro-urology Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
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 Gastroenterology & Urology devices follow this clearance model.