Cleared Traditional

K874255 - ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.

K874255 is an FDA 510(k) clearance for ND:YAG SURGICAL LASER FOR ENDO. GASTRO/..., manufactured by Minnesota Laser Corp.. The device is a Class 2 Gastroenterology & Urology device with product code LNK cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K874255 · Minnesota Laser Corp. · Gastroenterology & Urology device
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Jul 1988
Decision
266d
Days
Class 2
Risk

K874255 is an FDA 510(k) clearance for the ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.. Classified as Laser For Gastro-urology Use (product code LNK), Class II - Special Controls.

Submitted by Minnesota Laser Corp. (Minneapolis, US). The FDA issued a Cleared decision on July 12, 1988 after a review of 266 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Minnesota Laser Corp. devices

FDA 510(k) Submission Details - K874255

510(k) Number K874255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1987
Decision Date July 12, 1988
Days to Decision 266 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
135d slower than avg
Panel avg: 131d · This submission: 266d
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 35
Devices cleared under the same product code (LNK) and FDA review panel - the closest regulatory comparables to K874255.
MDL-2000 LASERTRIPTER
K901723 · Candela Laser Corp. · Jul 1990
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
ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY
K875039 · Surgilase, Inc. · Apr 1988
MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL
K880171 · Cooper Lasersonics, Inc. · Apr 1988
KTP/532 LASER
K873330 · Laserscope · Nov 1987