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510(k) K131362

INMODE WMBODY DEVICE by Inmode MD , Ltd. — Product Code NUV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2013
Date Received
May 13, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Vacuum, Light Induced Heating
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

The device is intended to temporarily alter the appearance of cellulite

Other clearances by Inmode MD , Ltd.

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  • K191855 — EmFace Device (October 29, 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)

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