FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Optimas MAX System
K Number: K251632
·
Decision Jun 26, 2025
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
15
Review Days
29
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Basic Information
- Device Name
- Optimas MAX System
- K Number
- K251632
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- InMode , Ltd.
- Date Received
- May 28, 2025
- Decision Date
- June 26, 2025
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by InMode , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K251254 | Ignite RF System | Jan 15, 2026 | 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 |
| K201285 | InMode Evolve System with the Tone Applicator | Mar 5, 2021 | Substantially Equivalent |