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

Devices@FDA
  • Print
  • Share
  • E-mail
-
 
Help | Download Files | More about CDRH 510(K)

New Search Back to Search Results
Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K240017
Device Name InMode System with the Morpheus8 90 Applicator
Applicant
InMode , Ltd.
Tabor Bldg., Shaar Yokneam Pob 44
Yokneam Illit,  IL 2069200
Applicant Contact Suhair Francis
Correspondent
Hogan Lovells US LLP
1735 Market St.
Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/02/2024
Decision Date 06/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
  We welcome your comments and feedback about Devices@FDA.
-
-