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510(k) K200293

InMode System with vTone Applicator by Inmode , Ltd. — Product Code KPI

Clearance Details

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

Device Classification

Device Name
Stimulator, Electrical, Non-Implantable, For Incontinence
Device Class
Class II
Regulation Number
876.5320
Review Panel
GU
Submission Type

Other clearances by Inmode , Ltd.

  • K251254 — Ignite RF System (January 15, 2026)
  • K251632 — Optimas MAX System (June 26, 2025)
  • 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 KPI

  • K251760 — Well-Life Incontinence Stimulation System (WL-2405i(P)) (February 12, 2026)
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  • K243079 — NeuroTrac® MyoPlus Pro (MYO120U) (June 26, 2025)
  • K241862 — Levina Pelvic Floor Muscle Stimulator (RS-48) (March 27, 2025)
  • K241516 — BTL-398 (February 10, 2025)
  • K241899 — Pelvic Floor Stimulator (Intrelief PFE) (November 27, 2024)
  • K234061 — StarFormer (July 1, 2024)
  • K233576 — Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505 (February 23, 2024)
  • K231166 — Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscl (January 18, 2024)
  • K230983 — Unicare (K-UNICARE-USA) (October 20, 2023)