Identifiers
- 510(k) Number
- K251632 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Optimas MAX System is a device used in general and plastic surgery procedures. It is designed to perform specific surgical functions as indicated by its product code classification.
The system is supplied by InMode, Ltd. and has received FDA 510(k) clearance with a decision code of SESE. It is intended for use in clinical settings where appropriate regulatory approvals are in place.
Frequently asked questions
What is the Optimas MAX System used for?
The Optimas MAX System is designed for use in general and plastic surgery procedures to perform specific surgical functions as indicated by its product code classification. It is intended for clinical settings where appropriate regulatory approvals are in place.
How is the Optimas MAX System supplied?
The Optimas MAX System is supplied by InMode, Ltd., a medical device manufacturer. The system is provided in configurations appropriate for its intended surgical applications in clinical environments.
What is the regulatory status of the Optimas MAX System?
The Optimas MAX System has received FDA 510(k) clearance with a decision code of SESE, indicating it is substantially equivalent to predicate devices. It is classified under product code GEX and was reviewed by the General, Plastic Surgery advisory committee.
What are the specifications of the Optimas MAX System?
The Optimas MAX System is classified under product code GEX and has a special clearance type. It was submitted by InMode, Ltd. and received FDA clearance on 2025-06-26, with the submission received on 2025-05-28. The system is designed for specific surgical functions in general and plastic surgery procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251632 | Class II | Active |
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Manufacturer
- Manufacturer
- InMode , Ltd.
Sources (1)
- FDA 510(k) K251632 24 fields · synced Sep 21, 2026