Device details
FDA 510(k) registration fields
- K number
- K241600
- Device name
- Dermablate
- Country / region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-06-04
- Decision date
- 2024-07-03
- Submission type
- Special
- Technology type
- CO2(AI inferred)
- Clinical applications
- Skin resurfacingSurgical cutting
- Primary application
- Skin resurfacing
- Classification source
- AI classified
