Device details
FDA 510(k) registration fields
- K number
- K240497
- Device name
- Smartxide Tetra Pro
- Company
- El.En S.P.A.
- Country / region
- Italy(IT)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-02-20
- Decision date
- 2024-03-12
- Submission type
- Special
- Technology type
- CO2(AI inferred)
- Clinical applications
- Skin resurfacingSurgical cutting
- Primary application
- Skin resurfacing
- Classification source
- AI classified
