Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
510(k) Number K161565
Device Name DUO
Applicant
Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd
10-11th Floor, Bensi Bldg., New High-Tech-Park,
Ganli Village, Buji District
Shenzhen,  CN
Applicant Contact Juan Ye
Correspondent
Sgs-Cstc Standards Technical Services Co., Ltd.
198 Kezhu Rd., Scientech Park Guangzhou
Guangzhou,  CN
Correspondent Contact Iris Fung
Regulation Number878.4810
Classification Product Code
ONF  
Subsequent Product Code
OHT  
Date Received06/06/2016
Decision Date 09/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-