Evolve System with the T3 Applicator
FDA 510(k) K210877 · InMode , Ltd.
510(k) numberK210877
Submission
- Device name
- Evolve System with the T3 Applicator
- Applicant
- InMode , Ltd.
Yokneam, IL - Received
- March 24, 2021
- Decision date
- July 19, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PBX – Massager, Vacuum, Radio Frequency Induced Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.
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More from Xod, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251254 | Ignite RF SystemGEI · Traditional | 01/15/2026SE |
| K251632 | Optimas MAX SystemGEX · Special | 06/26/2025SE |
| 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 |
| K201285 | InMode Evolve System with the Tone ApplicatorIPF · Traditional | 03/05/2021SE |
Questions and answers
When was Evolve System with the T3 Applicator cleared by the FDA?
Evolve System with the T3 Applicator (K210877) received a 510(k) decision of Substantially Equivalent on July 19, 2021, 117 days after the submission was received.
What is the product code of K210877?
The FDA product code is PBX – Massager, Vacuum, Radio Frequency Induced Heat, a Class II (moderate risk) device regulated under 21 CFR 878.4400.