Cleared Traditional

K863428 - SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAG

K863428 is an FDA 510(k) clearance for SINGLE USE LASER FIBER DELIVERY SYSTEM ..., manufactured by Laser Media. The device is a Class 2 Gastroenterology & Urology device with product code LNK cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K863428 · Laser Media · Gastroenterology & Urology device
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Dec 1986
Decision
90d
Days
Class 2
Risk

K863428 is an FDA 510(k) clearance for the SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAG. Classified as Laser For Gastro-urology Use (product code LNK), Class II - Special Controls.

Submitted by Laser Media (Hauppauge, US). The FDA issued a Cleared decision on December 3, 1986 after a review of 90 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 Laser Media devices

FDA 510(k) Submission Details - K863428

510(k) Number K863428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1986
Decision Date December 03, 1986
Days to Decision 90 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
41d faster than avg
Panel avg: 131d · This submission: 90d
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 K863428.
MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.
K871032 · Directed Energy, Inc. · May 1987
MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO.
K871030 · Directed Energy, Inc. · May 1987
10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH
K871031 · Directed Energy, Inc. · May 1987
LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM
K862598 · Laserscope · Nov 1986
CONTACT TIPS
K861955 · Cooper Lasersonics, Inc. · Aug 1986
ENDOSCOPIC ELECTROSURGICAL FIBEROPTIC PROBE
K861331 · Trimedyne, Inc. · Aug 1986