InMode RF System
FDA 510(k) K240780 · InMode , Ltd.
510(k) numberK240780
Submission
- Device name
- InMode RF System
- Applicant
- InMode , Ltd.
Yokneam Illit, IL - Received
- March 21, 2024
- Decision date
- July 24, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
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).
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| K240017 | InMode System with the Morpheus8 90 ApplicatorGEI · Traditional | 06/13/2024SE |
| K233642 | InMode RF SystemGEI · Traditional | 03/20/2024SE |
| K231495 | The Evolve System with the Transform ApplicatorGEI · Traditional | 10/13/2023SE |
| K231790 | The InMode System with the Morpheus8 ApplicatorsGEI · Special | 07/20/2023SE |
| K221571 | InMode Multi-systemGEX · Special | 06/30/2022SE |
| K210877 | Evolve System with the T3 ApplicatorPBX · Traditional | 07/19/2021SE |
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Questions and answers
When was InMode RF System cleared by the FDA?
InMode RF System (K240780) received a 510(k) decision of Substantially Equivalent on July 24, 2024, 125 days after the submission was received.
What is the product code of K240780?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.