FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
InMode Evolve System with the Tone Applicator
K Number: K201285
·
Decision Mar 5, 2021
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
15
Review Days
296
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Basic Information
- Device Name
- InMode Evolve System with the Tone Applicator
- K Number
- K201285
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- InMode , Ltd.
- Date Received
- May 13, 2020
- Decision Date
- March 5, 2021
- Product Code
- IPF
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by InMode , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K251254 | Ignite RF System | Jan 15, 2026 | Substantially Equivalent |
| K251632 | Optimas MAX System | Jun 26, 2025 | Substantially Equivalent |
| K242598 | DEFINE System (AG612444A) | Nov 14, 2024 | Substantially Equivalent |
| K240780 | InMode RF System | Jul 24, 2024 | Substantially Equivalent |
| K240017 | InMode System with the Morpheus8 90 Applicator | Jun 13, 2024 | Substantially Equivalent |
| K233642 | InMode RF System | Mar 20, 2024 | Substantially Equivalent |
| K231495 | The Evolve System with the Transform Applicator | Oct 13, 2023 | Substantially Equivalent |
| K231790 | The InMode System with the Morpheus8 Applicators | Jul 20, 2023 | Substantially Equivalent |
| K221571 | InMode Multi-system | Jun 30, 2022 | Substantially Equivalent |
| K210877 | Evolve System with the T3 Applicator | Jul 19, 2021 | Substantially Equivalent |