Last synced on 24 January 2025 at 11:04 pm

InMode System with the Morpheus8 (Fractora) Applicators

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192695
510(k) Type
Special
Applicant
Inmode MD Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
12/27/2019
Days to Decision
92 days
Submission Type
Summary

InMode System with the Morpheus8 (Fractora) Applicators

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192695
510(k) Type
Special
Applicant
Inmode MD Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
12/27/2019
Days to Decision
92 days
Submission Type
Summary