Cleared Special

K093502 - VARI-LASE ENDOVENOUS LASER CONSOLE

K093502 is the FDA 510(k) clearance for VARI-LASE ENDOVENOUS LASER CONSOLE by Vascular Solutions, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Special 510(k) pathway after a 56-day FDA review.

K093502 · Vascular Solutions, Inc. · General & Plastic Surgery device
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Jan 2010
Decision
56d
Days
Class 2
Risk

K093502 is an FDA 510(k) clearance for the VARI-LASE ENDOVENOUS LASER CONSOLE. 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 Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 7, 2010 after a review of 56 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Vascular Solutions, Inc. devices

Submission Details

510(k) Number K093502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2009
Decision Date January 07, 2010
Days to Decision 56 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 115d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 1059
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K093502.
MODEL VISULAS 532S LASER WITH THE VITE OPTION
K100035 · Carl Zeiss Meditec, AG · Mar 2010
VERSAPULSE MODEL P20 LASER SYSTEM
K100228 · Lumenis, Inc. · Feb 2010
MODIFIED STRAIGHT FIRE LASER FIBER
K100078 · Boston Scientific Corp · Feb 2010
ACCUMAX
K093691 · Boston Scientific Corp · Dec 2009
GREENLIGHT XPS LASER SYSTEM
K092735 · American Medical Systems, Inc. · Nov 2009
CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH
K091537 · Cynosure, Inc. · Sep 2009