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 K242598
Device Name DEFINE System (AG612444A)
Applicant
Inmode , Ltd.
Tabor Bldg., Shaar Yokneam
Yokneam,  IL 2069200
Applicant Contact Ahava Stein
Correspondent
Inmode , Ltd.
Tabor Bldg., Shaar Yokneam
Yokneam,  IL 2069200
Correspondent Contact Ahava Stein
Regulation Number878.4400
Classification Product Code
PBX  
Subsequent Product Codes
GEI   ISA   NUV  
Date Received08/30/2024
Decision Date 11/14/2024
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
-
-