Manufacturer
Shenzhen Chuangtong Yigou Technology Co., Ltd.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)
Shenzhen Chuangtong Yigou Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code OHT· 21 CFR 878.4810
Product code
OHT
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- 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)
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-12-17
- Decision date
- 2026-03-11
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- FaceBodyLegsBikini / Brazilian
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Intended Use
Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Device Description
Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed eighteen models with the same IPL technology for hair removal, which is model CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017, DT017 Pro, DT025 Pro, DT025. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.0cm2 (Model CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012 , CTU015, CTU X) and 4.2cm2 (Model DT015 Pro, DT015, DT017, DT017 Pro, DT025, DT025 Pro) that is suitable for multiple hair removal areas, such as upper lip, chin, armpits, legs, arms, bikini area, chest, back, abdomen. The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the Hair Removal Device has the Ice-cooling function (Model: CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12) and Sapphire Ice-cooling function (Model: CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017, DT017 Pro, DT025 Pro, DT025), which will be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.
Summary parsed at:2026-06-11 04:25:33 UTC
Predicate devices
4IPL Cooling Hair Removal Device
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)
Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)
IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)
K254047 references 4 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K254047 as a predicate
