Device details
FDA 510(k) registration fields
- K number
- K214049
- Device name
- Leaseir MHR Xcell
- Company
- Leaseir Technologies, Slu
- Country / region
- Spain(ES)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-12-27
- Decision date
- 2022-06-02
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removalAcne treatment
- Primary application
- Hair removal
- Classification source
- AI classified
