Device details
FDA 510(k) registration fields
- K number
- K241205
- Device name
- Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)
- Country / region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-04-30
- Decision date
- 2024-09-09
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- UnderarmFaceLegsOther
- Primary application
- Other
- Classification source
- AI classified
