• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K122528
Model 8850-0001
Device Name ULTHERA SYSTEM
Original Applicant
ULTHERA, INC.
1840 s stapley dr suite 200
mesa,  AZ  85204
Original Contact suzon lommel
Regulation Number878.4590
Classification Product Code
OHV  
Date Received08/20/2012
Decision Date 08/28/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-