Skip to product information
1 of 1

FDA 510(k) K150409, VIVACE Electrosurgical System, by Sung Hwan E&B Co.,Ltd

FDA 510(k) K150409, VIVACE Electrosurgical System, by Sung Hwan E&B Co.,Ltd

Regular price $153.34 USD
Regular price Sale price $153.34 USD
Sale Sold out

510(K) Number: K150409
Device Name: VIVACE Electrosurgical System
Manufacturer: Sung Hwan E&B Co.,Ltd
Device Classification Name: skin resurfacing rf applicator
Regulation Number: 878.4400
Classification Product Code: OUH
Date Received: 02/18/2015
Decision Date: 01/15/2016
Regulation Medical Specialty: General & Plastic Surgery

NOTE: 53 out of 99 pages fully redacted and most removed from the file.

View full details
FOIA Pro

This drug has a lot more FDA history than one product page can show

FOIA Pro gives you full-text search across 70,000+ FDA FOIA records, from 2020 through today, plus a monthly monitor tracking new requests as they close.
  • Full-text search across every FDA FOIA log since 2020
  • Warning letters, approval records, and correspondence in one place
  • Monthly FDA FOIA Monitor newsletter, included
  • Cancel anytime, monthly or annual billing
Get FOIA Pro
Live search · FOIA database
Searching related FDA records…
ClosedTypeSubjectOutcome