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) K262524
Substantially EquivalentONE BEAUTY Technology Co., Ltd.
FDA 510(k) clearance K262524 for Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B), Substantially Equivalent on 2026-09-18. Applicant: ONE BEAUTY Technology Co., Ltd.. Device class: 2.
Summary
Sapphire Cooling IPL Hair Removal Device is from ONE BEAUTY Technology Co., Ltd., filed under product code OHT (Light Based Over-The-Counter Hair Removal). The name lists six models: Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, and Ice 2.2B. The record doesn't say how they differ.
Class II, 21 CFR 878.4810. General, Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
ONE BEAUTY filed from Shenzhen, China. The decision came 58 calendar days after FDA received it (July 22 to September 18, 2026).
Clearance details
- Applicant
- ONE BEAUTY Technology Co., Ltd.
- Product code
- Product code OHT
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code OHT
view all- K262352 — IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202)
- K261975 — Braun Aura 7 (6041)
- K261977 — Braun Aura 9 (6042)
- K261705 — Hair Removal Device (R3C16-G Pro, R3C16-V Pro)
- K261325 — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
Data sourced from openFDA. This site is unofficial and independent of the FDA.