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)
FDA 510(k) clearance K254047 · decided 2026-03-11
Clearance details
- K-number
- K254047
- Device name
- 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)
- Applicant
- Shenzhen Chuangtong Yigou Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-12-17
- Decision date
- 2026-03-11
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- OHT
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.