Cleared Traditional

K850728 - MODEL 4000 ND:YAG LASER FOR GASTROINTES...

K850728 is an FDA 510(k) clearance for MODEL 4000 ND:YAG LASER FOR GASTROINTES..., manufactured by Cooper Lasersonics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LNK cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K850728 · Cooper Lasersonics, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Apr 1985
Decision
45d
Days
Class 2
Risk

K850728 is an FDA 510(k) clearance for the MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE. Classified as Laser For Gastro-urology Use (product code LNK), Class II - Special Controls.

Submitted by Cooper Lasersonics, Inc. (Santa Clara, US). The FDA issued a Cleared decision on April 8, 1985 after a review of 45 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 Cooper Lasersonics, Inc. devices

FDA 510(k) Submission Details - K850728

510(k) Number K850728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1985
Decision Date April 08, 1985
Days to Decision 45 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
85d faster than avg
Panel avg: 130d · This submission: 45d
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 25
Devices cleared under the same product code (LNK) and FDA review panel - the closest regulatory comparables to K850728.
S.L.T. LASER DELIVERY SYSTEM FOR YAG LASER
K854669 · Surgical Laser Technologies, Inc. · Feb 1986
LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM
K854027 · Laserscope · Dec 1985
HOTIP HEMOSTATIC PROBE
K843628 · Trimedyne, Inc. · Nov 1985
LASER FOR GENITOURINARY APPLIC. 4000
K843240 · Cooper Lasersonics, Inc. · Oct 1984
COOPER LASERSONICS, 8000 ND.YAGLASER
K841869 · Cooper Lasersonics, Inc. · Aug 1984
YAG LASER 8000 - LOWER GI APPLICAT
K840142 · Cooper Lasersonics, Inc. · May 1984