Cleared Traditional

K875039 - ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY

K875039 is an FDA 510(k) clearance for ND:YAG 100 SURGICAL LASER FOR GASTRO. A..., manufactured by Surgilase, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LNK cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K875039 · Surgilase, Inc. · Gastroenterology & Urology device
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Apr 1988
Decision
128d
Days
Class 2
Risk

K875039 is an FDA 510(k) clearance for the ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY. Classified as Laser For Gastro-urology Use (product code LNK), Class II - Special Controls.

Submitted by Surgilase, Inc. (Warwick, US). The FDA issued a Cleared decision on April 13, 1988 after a review of 128 days - within the typical 510(k) review window.

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 Surgilase, Inc. devices

FDA 510(k) Submission Details - K875039

510(k) Number K875039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1987
Decision Date April 13, 1988
Days to Decision 128 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
3d faster than avg
Panel avg: 131d · This submission: 128d
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 34
Devices cleared under the same product code (LNK) and FDA review panel - the closest regulatory comparables to K875039.
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
MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL
K880171 · Cooper Lasersonics, Inc. · Apr 1988
KTP/532 LASER
K873330 · Laserscope · Nov 1987
SERIES 2900 SYNTHETIC CONTACT TIPS, GU USE
K871865 · Sharplan Lasers, Inc. · Sep 1987