Device details
FDA 510(k) registration fields
- K number
- K230549
- Device name
- IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG
- Country / region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-02-28
- Decision date
- 2023-04-25
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- FaceBodyLegsUnderarm
- Primary application
- Body
- Classification source
- AI classified
