510(k) K182325

InMode RF System by Inmode MD , Ltd. — Product Code GEI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 26, 2018
Date Received: August 27, 2018
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Electrosurgical, Cutting & Coagulation & Accessories
Device Class: Class II
Regulation Number: 878.4400
Review Panel: SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Inmode MD , Ltd.

K210492 — InMode RF Pro System (July 12, 2021)
K192695 — InMode System with the Morpheus8 (Fractora) Applicators (December 27, 2019)
K191855 — EmFace Device (October 29, 2019)
K183450 — EmBody System (June 20, 2019)
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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