Device details
FDA 510(k) registration fields
- K number
- K251000
- Device name
- Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)
- Country / region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-04-01
- Decision date
- 2025-06-30
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- UnderarmLegsArmsBikini / Brazilian
- Primary application
- Underarm
- Classification source
- AI classified
