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 K231394
Device Name Intense Pulsed Light System
Applicant
Smedtrum Medical Technology Co., Ltd.
1f., # 8, Ln. 97, Wugong Rd., Xinzhuang Dist.
New Taipei City,  TW 248016
Applicant Contact Crimson Wu
Correspondent
Smedtrum Medical Technology Co., Ltd.
1f., # 8, Ln. 97, Wugong Rd., Xinzhuang Dist.
New Taipei City,  TW 248016
Correspondent Contact Crimson Wu
Regulation Number878.4810
Classification Product Code
ONF  
Date Received05/15/2023
Decision Date 08/09/2023
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
-
-