Cleared Traditional

K871516 - SL-100 ND:YAG LASER FOR UROLOGIC SURGERY

K871516 is the FDA 510(k) clearance for SL-100 ND:YAG LASER FOR UROLOGIC SURGERY by Medical Energy, Inc.. It is a Class 2 Gastroenterology & Urology device (product code LNK) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K871516 · Medical Energy, Inc. · Gastroenterology & Urology device
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Jul 1987
Decision
80d
Days
Class 2
Risk

K871516 is an FDA 510(k) clearance for the SL-100 ND:YAG LASER FOR UROLOGIC SURGERY. Classified as Laser For Gastro-urology Use (product code LNK), Class II - Special Controls.

Submitted by Medical Energy, Inc. (Pensacola, US). The FDA issued a Cleared decision on July 9, 1987 after a review of 80 days - a notably fast clearance cycle.

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: 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 Medical Energy, Inc. devices

Submission Details

510(k) Number K871516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1987
Decision Date July 09, 1987
Days to Decision 80 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
50d faster than avg
Panel avg: 130d · This submission: 80d
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.

Regulatory Peers - LNK Laser For Gastro-urology Use

Devices cleared under the same product code (LNK) and FDA review panel - the closest regulatory comparables to K871516.
MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE
K880193 · Sharplan Lasers, Inc. · Apr 1988
MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE
K880256 · Sharplan Lasers, Inc. · Apr 1988
SERIES 2900 SYNTHETIC CONTACT TIPS, GU USE
K871865 · Sharplan Lasers, Inc. · Sep 1987
SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE
K871348 · Sharplan Lasers, Inc. · Jun 1987