Cleared Traditional

K040424 - LASER ENDOSCOPIC DECOMPRESSION KIT

K040424 is an FDA 510(k) clearance for LASER ENDOSCOPIC DECOMPRESSION KIT, manufactured by Clarus Medical, LLC. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K040424 · Clarus Medical, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
83d
Days
Class 2
Risk

K040424 is an FDA 510(k) clearance for the LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY K.... Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Clarus Medical, LLC (Minneapolis, US). The FDA issued a Cleared decision on May 11, 2004 after a review of 83 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery 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 Clarus Medical, LLC devices

FDA 510(k) Submission Details - K040424

510(k) Number K040424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2004
Decision Date May 11, 2004
Days to Decision 83 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 115d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEX Device Classification - Class 2, Special Controls

Product Code GEX Powered Laser Surgical Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEX Powered Laser Surgical Instrument

All 1534
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K040424.
TRIMEDYNE HOLMIUM LASER SYSTEMS
K041660 · Trimedyne, Inc. · Sep 2004
WATERLASE
K031140 · Biolase Technology, Inc. · Jul 2004
PHOTOSILK PULSED LIGHT SYSTEM
K041095 · Cynosure, Inc. · May 2004
SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER
K040289 · Cynosure, Inc. · Apr 2004
COOLTOUCH
K040131 · New Star Lasers, Inc. · Apr 2004
PALOMAR LUXV HANDPIECE
K040081 · Palomar Medical Technologies, Inc. · Apr 2004