K254047

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) 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. CN
Product code: OHT — Light Based Over-The-Counter Hair Removal
Decision date: 2026-03-11
Date received: 2025-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain

Also available from FDA: K254047.pdf

Official FDA record: K254047

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.