VIVACE Electrosurgical System— 510(k) K150409

Name: FDA 510(k) clearance K150409
Creator: U.S. Food and Drug Administration
Published: 2016-01-15

Substantially Equivalent

Sung Hwan E&B Co.,Ltd

FDA 510(k) clearance K150409 for VIVACE Electrosurgical System, Substantially Equivalent on 2016-01-15. Applicant: Sung Hwan E&B Co.,Ltd. Device class: 2.

Clearance details

Applicant: Sung Hwan E&B Co.,Ltd
Product code: Code OUH
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2015-02-18
Decision date: 2016-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongdong-Gu, KR

Download summary PDF View on FDA.gov ↗

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K101510 — FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR2011-02-17

Recalls naming K150409

K-number listed on FDA's recall record

Z-0444-2021 — SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.Class II·Terminated·Aesthetics Biomedical, Inc.·20200313

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150409.

Data sourced from openFDA. This site is unofficial and independent of the FDA.