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510(k) K191855

EmFace Device by Inmode MD , Ltd. — Product Code PBX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2019
Date Received
July 10, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Vacuum, Radio Frequency Induced Heat
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.

Other clearances by Inmode MD , Ltd.

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  • K192695 — InMode System with the Morpheus8 (Fractora) Applicators (December 27, 2019)
  • K183450 — EmBody System (June 20, 2019)
  • K182325 — InMode RF System (September 26, 2018)
  • K180719 — InMode Diolaze System (June 14, 2018)
  • K180189 — InMode System with Fractora3D/3D-90 Applicators (June 1, 2018)
  • K173677 — InMode VLaze (February 23, 2018)
  • K172302 — InMode PLUS System (December 8, 2017)
  • K171593 — InMode RF System (October 10, 2017)
  • K170738 — InMode Diolaze XL (August 7, 2017)

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