Cleared Traditional

K871513 - SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI

K871513 is an FDA 510(k) clearance for SL-100 ND:YAG LASER FOR PALLIATION OF G..., manufactured by Medical Energy, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LNK cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K871513 · Medical Energy, Inc. · Gastroenterology & Urology device
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Jul 1987
Decision
80d
Days
Class 2
Risk

K871513 is an FDA 510(k) clearance for the SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI. 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.

FDA 510(k) Submission Details - K871513

510(k) Number K871513 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 131d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNK Device Classification - Class 2, Special Controls

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

All 59
Devices cleared under the same product code (LNK) and FDA review panel - the closest regulatory comparables to K871513.
ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO.
K872630 · Hgm, Inc. · Aug 1987
FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USE
K872350 · Laser Media · Aug 1987
UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM
K872031 · Laser Media · Aug 1987
SL-100 ND:YAG LASER FOR RECTAL PATHO. & HEMORRHOID
K871514 · Medical Energy, Inc. · Jul 1987
SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING
K871515 · Medical Energy, Inc. · Jul 1987
SL-100 ND:YAG LASER FOR UROLOGIC SURGERY
K871516 · Medical Energy, Inc. · Jul 1987
K871513 · SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI
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