Device details
FDA 510(k) registration fields
- K number
- K252753
- Device name
- Vydence Family of Lasers
- Country / region
- Brazil(BR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-08-29
- Decision date
- 2026-01-24
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Acne treatmentPigment treatmentVascular treatmentHair removal
- Primary application
- Hair removal
- Classification source
- AI classified
