InMode Evolve System with the Tone Applicator
FDA 510(k) K201285 · InMode , Ltd.
510(k) numberK201285
Submission
- Device name
- InMode Evolve System with the Tone Applicator
- Applicant
- InMode , Ltd.
Yokneam, IL - Received
- May 13, 2020
- Decision date
- March 5, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IPF – Stimulator, Muscle, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
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| K242598 | DEFINE System (AG612444A)PBX · Special | 11/14/2024SE |
| K240780 | InMode RF SystemGEI · Traditional | 07/24/2024SE |
| 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 |
Questions and answers
When was InMode Evolve System with the Tone Applicator cleared by the FDA?
InMode Evolve System with the Tone Applicator (K201285) received a 510(k) decision of Substantially Equivalent on March 5, 2021, 296 days after the submission was received.
What is the product code of K201285?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.