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InMode System with Fractora3D/3D-90 Applicators

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
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)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
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