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 Massager, Vacuum, Radio Frequency Induced Heat
510(k) Number K172004
Device Name truSculpt
Applicant
Cutera, Inc.
3240 Bayshore Blvd.
Brisbane,  CA  94005
Applicant Contact Bradley Renton
Correspondent
Cutera, Inc.
3240 Bayshore Blvd.
Brisbane,  CA  94005
Correspondent Contact Bradley Renton
Regulation Number878.4400
Classification Product Code
PBX  
Subsequent Product Code
GEI  
Date Received07/03/2017
Decision Date 08/02/2017
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
-
-