Last synced on 14 November 2025 at 11:06 pm

InMode System with Fractora3D/3D-90 Applicators

Page Type
Cleared 510(K)
510(k) Number
K180189
510(k) Type
Traditional
Applicant
Inmode MD Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
6/1/2018
Days to Decision
129 days
Submission Type
Summary

InMode System with Fractora3D/3D-90 Applicators

Page Type
Cleared 510(K)
510(k) Number
K180189
510(k) Type
Traditional
Applicant
Inmode MD Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
6/1/2018
Days to Decision
129 days
Submission Type
Summary