Device details
FDA 510(k) registration fields
- K number
- K241092
- Device name
- Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT
- Company
- Quanta System Spa
- Country / region
- Italy(IT)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-04-22
- Decision date
- 2024-10-10
- Submission type
- Traditional
- Technology type
- CO2(AI inferred)
- Clinical applications
- Surgical cuttingSkin resurfacing
- Primary application
- Surgical cutting
- Classification source
- AI classified
