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 System, Suction, Lipoplasty For Removal
510(k) Number K190555
Device Name PowerX Lipo System
Applicant
Solta Medical
11720 N. Creek Pkway N.
Suite 100
Bothell,  WA  98011
Applicant Contact Manal Morcos
Correspondent
Manal Morcos, MS Bme, MBA
400 Somerset Corporate Blvd.
Bridgewater,  NJ  08807
Correspondent Contact Manal Morcos
Regulation Number878.5040
Classification Product Code
QPB  
Date Received03/05/2019
Decision Date 05/01/2019
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
-
-