Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)— 510(k) K254047
Substantially EquivalentShenzhen Chuangtong Yigou Technology Co., Ltd.
FDA 510(k) clearance K254047 for Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025), Substantially Equivalent on 2026-03-11. Applicant: Shenzhen Chuangtong Yigou Technology Co., Ltd.. Device class: 2.
Summary
Shenzhen Chuangtong Yigou Technology's Hair Removal Device is filed under OHT, light-based over-the-counter hair removal. The name lists 18 models, from CT10 to DT025.
Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Shenzhen Chuangtong Yigou Technology filed from Shenzhen, China. Review took 84 calendar days (December 17, 2025 to March 11, 2026).
Clearance details
- Applicant
- Shenzhen Chuangtong Yigou 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)
- K262524 — Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)
- K261705 — Hair Removal Device (R3C16-G Pro, R3C16-V Pro)
More clearances from Shenzhen Chuangtong Yigou Technology Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.