510(k) clearance
Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)
- 510(k) number
- K262524
- Applicant
- ONE BEAUTY Technology Co., Ltd.
- Decision date
- Sep 18, 2026
- Date received
- Jul 22, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OHT
- Device type
- Light Based Over-The-Counter Hair Removal
- Device class
- Class II
- Regulation
- 21 CFR 878.4810
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Shenzhen, CN