Device details
FDA 510(k) registration fields
- K number
- K250253
- Device name
- IPL Hair Removal Device (KCA511/KCA516/KCA522)
- Country / region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-01-28
- Decision date
- 2025-05-06
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- UnderarmBikini / BrazilianArmsLegs
- Primary application
- Underarm
- Classification source
- AI classified
