Cleared Traditional

VEINWAVE, TC3000 (K083352) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K083352 · Newlands Clinical Trials, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
211d
Days
Class 2
Risk

K083352 is an FDA 510(k) clearance for the VEINWAVE, TC3000. Classified as Electrosurgical Coagulation For Aesthetic (product code ONQ), Class II - Special Controls.

Submitted by Newlands Clinical Trials, Ltd. (Claremont, US). The FDA issued a Cleared decision on June 12, 2009 after a review of 211 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Newlands Clinical Trials, Ltd. devices

Submission Details

510(k) Number K083352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2008
Decision Date June 12, 2009
Days to Decision 211 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
96d slower than avg
Panel avg: 115d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ONQ Electrosurgical Coagulation For Aesthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition For The Treatment Of Spider Vein Or Telangiectasia By Thermocoagulation.
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.