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510(k) K201285

InMode Evolve System with the Tone Applicator by Inmode , Ltd. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2021
Date Received
May 13, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

Other clearances by Inmode , Ltd.

  • K251254 — Ignite RF System (January 15, 2026)
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  • K242598 — DEFINE System (AG612444A) (November 14, 2024)
  • K240780 — InMode RF System (July 24, 2024)
  • K240017 — InMode System with the Morpheus8 90 Applicator (June 13, 2024)
  • K233642 — InMode RF System (March 20, 2024)
  • K231495 — The Evolve System with the Transform Applicator (October 13, 2023)
  • K231790 — The InMode System with the Morpheus8 Applicators (July 20, 2023)
  • K221571 — InMode Multi-system (June 30, 2022)
  • K210877 — Evolve System with the T3 Applicator (July 19, 2021)

Other clearances for product code IPF

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  • K240348 — Quantum Mitohormesis (QMT) (M2101) (December 19, 2024)
  • K240992 — eMVFit (MVF-10M) (October 10, 2024)
  • K240234 — BTL-899MS (August 17, 2024)
  • K233098 — MYOTouch Muscle Stimulator (August 2, 2024)
  • K232786 — Stimulation System (PA series, PR series, S series and Q series) (May 16, 2024)
  • K233926 — accufit (March 21, 2024)
  • K233485 — M-Wave (January 26, 2024)