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 K233996
Device Name Ulthera System (UC-1 Control Unit PRIME)
Applicant
Ulthera, Inc.
1840 S. Stapley Dr.
Suite 200
Mesa,  AZ  85204
Applicant Contact Kim Kelly
Correspondent
Ulthera, Inc.
1840 S. Stapley Dr.
Suite 200
Mesa,  AZ  85204
Correspondent Contact Kim Kelly
Regulation Number878.4590
Classification Product Code
OHV  
Subsequent Product Code
IYO  
Date Received12/18/2023
Decision Date 02/22/2024
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
-
-