Device details
FDA 510(k) registration fields
- K number
- K234004
- Device name
- Medical diode laser systems (CHARISMA, REGAL)
- Company
- Reveal Lasers , Ltd.
- Country / region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-12-19
- Decision date
- 2025-02-20
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Skin resurfacingPigment treatmentSurgical cutting
- Primary application
- Skin resurfacing
- Classification source
- AI classified
