Cleared Traditional

EVRF SYSTEM (K130283) - FDA 510(k) Clearance

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

K130283 · F Care Systems NV · General & Plastic Surgery device
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Mar 2013
Decision
30d
Days
Class 2
Risk

K130283 is an FDA 510(k) clearance for the EVRF SYSTEM. Classified as Electrosurgical Coagulation For Aesthetic (product code ONQ), Class II - Special Controls.

Submitted by F Care Systems NV (Crofton, US). The FDA issued a Cleared decision on March 7, 2013 after a review of 30 days - a notably fast clearance 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: 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 F Care Systems NV devices

Submission Details

510(k) Number K130283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2013
Decision Date March 07, 2013
Days to Decision 30 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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.