Cleared Traditional

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)

K254047 · Shenzhen Chuangtong Yigou Technology Co., Ltd. · General & Plastic Surgery

Mar 2026

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K254047 is an FDA 510(k) clearance for the 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), a Light Based Over-the-counter Hair Removal (Class II — Special Controls, product code OHT), submitted by Shenzhen Chuangtong Yigou Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 11, 2026, 84 days after receiving the submission on December 17, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K254047 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 17, 2025
Decision Date	March 11, 2026
Days to Decision	84 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OHT — Light Based Over-the-counter Hair Removal
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4810
Definition	Over-the-counter Device Uses Thermal Energy To Kill Hair Follicles For Hair Removal.