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 Laser Surgical Instrument
510(k) Number K200331
Device Name Rapid Acoustic Pulse Device
Applicant
Soliton, Inc.
5304 Ashbrook Dr.
Houston,  TX  77081
Applicant Contact Leslie Honda
Correspondent
Hogan Levells US LLP
1735 Market St., Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/10/2020
Decision Date 03/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-