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 focused ultrasound for tissue heat or mechanical cellular disruption
510(k) Number K230019
Device Name SofWave System
Applicant
Sofwave Medical Ltd.
1 Ha-Otsma St.
Yokneam Ilit,  IL 2069200
Applicant Contact Ruthie Amir
Correspondent
Hogan Lovells US LLP
1735 Market Street, Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice M Hogan
Regulation Number878.4590
Classification Product Code
OHV  
Date Received01/03/2023
Decision Date 03/14/2023
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
-
-