Device details
FDA 510(k) registration fields
- K number
- K211761
- Device name
- UltraLase Flexible CO2 Laser Waveguide
- Country / region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-06-08
- Decision date
- 2021-07-30
- Submission type
- Special
- Technology type
- CO2(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
