Device details
FDA 510(k) registration fields
- K number
- K242595
- Device name
- Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)
- Country / region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-08-30
- Decision date
- 2024-11-07
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyOther
- Primary application
- Body
- Classification source
- AI classified
