Cleared Traditional

K880256 - MODEL 4060 N ND:YAG LASER FOR GASTROENT...

K880256 is the FDA 510(k) clearance for MODEL 4060 N ND:YAG LASER FOR GASTROENT... by Sharplan Lasers, Inc.. It is a Class 2 Gastroenterology & Urology device (product code LNK) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K880256 · Sharplan Lasers, Inc. · Gastroenterology & Urology device
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Apr 1988
Decision
85d
Days
Class 2
Risk

K880256 is an FDA 510(k) clearance for the MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE. Classified as Laser For Gastro-urology Use (product code LNK), Class II - Special Controls.

Submitted by Sharplan Lasers, Inc. (Allendale, US). The FDA issued a Cleared decision on April 14, 1988 after a review of 85 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 Sharplan Lasers, Inc. devices

Submission Details

510(k) Number K880256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1988
Decision Date April 14, 1988
Days to Decision 85 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
45d faster than avg
Panel avg: 130d · This submission: 85d
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

All 25
Devices cleared under the same product code (LNK) and FDA review panel - the closest regulatory comparables to K880256.
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 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
SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE
K871348 · Sharplan Lasers, Inc. · Jun 1987