Device details
FDA 510(k) registration fields
- K number
- K221623
- Device name
- FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm
- Country / region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-06-06
- Decision date
- 2023-03-10
- Submission type
- Traditional
- Technology type
- Laser fiber / delivery(AI inferred)
- Clinical applications
- Skin resurfacingOtherPigment treatmentAcne treatment
- Primary application
- Skin resurfacing
- Classification source
- AI classified
