Cleared Traditional

K850509 - ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM

K850509 is an FDA 510(k) clearance for ND:YAG FIBERLASE 100 MEDICAL LASER 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 59-day FDA review.

K850509 · Laser Media · Gastroenterology & Urology device
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Apr 1985
Decision
59d
Days
Class 2
Risk

K850509 is an FDA 510(k) clearance for the ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM. 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 April 8, 1985 after a review of 59 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 Laser Media devices

FDA 510(k) Submission Details - K850509

510(k) Number K850509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1985
Decision Date April 08, 1985
Days to Decision 59 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
72d faster than avg
Panel avg: 131d · This submission: 59d
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 K850509.
MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY
K860152 · Endo Lase, Inc. · Feb 1986
LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM
K854027 · Laserscope · Dec 1985
HOTIP HEMOSTATIC PROBE
K843628 · Trimedyne, Inc. · Nov 1985
MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE
K850728 · Cooper Lasersonics, Inc. · Apr 1985
ND:YAG LASER UROLOGICAL SURGERY
K844459 · Endo Lase, Inc. · Jan 1985
ND. YAG LASER RECTAL PATHOLOGY
K844460 · Endo Lase, Inc. · Jan 1985