Device details
FDA 510(k) registration fields
- K number
- K243465
- Device name
- Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate)
- Country / region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-11-08
- Decision date
- 2025-02-06
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
