Device details
FDA 510(k) registration fields
- K number
- K240222
- Device name
- Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)
- Company
- Aesthetic Technology, Ltd.
- Country / region
- United Kingdom(GB)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-01-26
- Decision date
- 2024-06-04
- Submission type
- Traditional
- Technology type
- LED(AI inferred)
- Clinical applications
- Acne treatmentVascular treatmentPigment treatmentOther
- Primary application
- Acne treatment
- Classification source
- AI classified
