Cleared Traditional

400um Perforator and Accessory Vein Ablation Kit (K181044) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K181044 · AngioDynamics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
77d
Days
Class 2
Risk

K181044 is an FDA 510(k) clearance for the 400um Perforator and Accessory Vein Ablation Kit. 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 AngioDynamics, Inc. (Marlborough, US). The FDA issued a Cleared decision on July 5, 2018 after a review of 77 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 AngioDynamics, Inc. devices

Submission Details

510(k) Number K181044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2018
Decision Date July 05, 2018
Days to Decision 77 days
Submission Type Traditional
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
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02215369 Completed Interventional Industry-sponsored

SeCure Endovenous Laser Treatment Study

Prospective Safety and Effectiveness Study: VenaCure Endovenous Laser Treatment (EVLT) 400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins

112
Patients (actual)
7
Sites
Treatment
Purpose
Open label
Masking
Condition studied Chronic Venous Insufficiency
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor Angiodynamics, Inc. (industry)
Started 2015-01-01 → Primary completion 2018-03-01 → Completed 2019-01-14
Primary outcome
Acute Primary Ablation Success
Secondary outcome
Technical Success
View full study on ClinicalTrials.gov

Regulatory Peers - GEX Powered Laser Surgical Instrument

All 632
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K181044.
Dental Diode Laser System
K180967 · Lazon Medical Laser Co., Ltd. · Jul 2018
Syneron CO2RE System
K181523 · Syneron-Candela Corp · Jul 2018
Fractional CO2 Surgical Laser System
K173359 · Ami, Inc. · Jul 2018
Beacon Advanced CO2 Laser System
K180993 · Omniguide, Inc. · Jun 2018
PICOPLUS Laser System
K173700 · Lutronic Corporation · Jun 2018
InMode Diolaze System
K180719 · Inmode MD , Ltd. · Jun 2018