Cleared Traditional

K150409 - VIVACE Electrosurgical System (FDA 510(k) Clearance)

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

K150409 · Sung Hwan E&B Co.,Ltd · General & Plastic Surgery device
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Jan 2016
Decision
331d
Days
Class 2
Risk

K150409 is an FDA 510(k) clearance for the VIVACE Electrosurgical System. Classified as Skin Resurfacing Rf Applicator (product code OUH), Class II - Special Controls.

Submitted by Sung Hwan E&B Co.,Ltd (Seongdong-Gu, KR). The FDA issued a Cleared decision on January 15, 2016 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

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Submission Details

510(k) Number K150409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2015
Decision Date January 15, 2016
Days to Decision 331 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
217d slower than avg
Panel avg: 114d · This submission: 331d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OUH Skin Resurfacing Rf Applicator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Skin Resurfacing
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.