mJOULE System and Accessories
FDA 510(k)Class II (US FDA 510(k))
by Sciton, Inc
Identifiers
- 510(k) Number
- K213350 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 mJOULE System and Accessories is a device used in general and plastic surgery procedures. It is substantially equivalent to a legally marketed device as determined by FDA 510(k) clearance.
The system is supplied by Sciton, Inc and was cleared via the traditional 510(k) pathway under product code GEX. It received FDA clearance on April 15, 2022, under K213350.
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 | K213350 | Class II | Active |
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Manufacturer
- Manufacturer
- Sciton, Inc
Sources (1)
- FDA 510(k) K213350 24 fields · synced Sep 23, 2026