Manufacturer
Shenzhen Chuangtong Yigou Technology Co., Ltd.Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)
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
Device details
FDA 510(k) registration fields
- K number
- K251000
- Device name
- Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-04-01
- Decision date
- 2025-06-30
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- UnderarmLegsArmsBikini / Brazilian
- Primary application
- Underarm
- Classification source
- AI classified
Indications for Use
Hand-held 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. The device is used for adults with Fitzpatrick skin types I - IV. Treatment areas include upper lip, chin, underarms, legs, arms, bikini area, chest, back, and abdomen.
Intended Use
Hand-held 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
Hand-held Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL). 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 powered by an external power adapter and its IPL emission activation is by finger switch. It has an irreplaceable light exit and can cover an area of 3.0cm2, suitable for multiple hair removal areas, such as upper lip, chin, underarms, legs, arms, bikini area, chest, back, abdomen. The device contains a skin sensor to detect appropriate skin contact, ensuring that the treatment light pulses are emitted only when in full contact with the skin. Additionally, it has a cooling function (suitable for model CT05, CT06, CT07, CT08, CT09) that can be activated throughout the hair removal process to cool down the treatment area's temperature.
Summary parsed at:2026-06-11 04:29:25 UTC
Predicate devices
3IPL Hair Removal Device Joy Version
IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD
Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200
K251000 references 3 predicate/reference devices
Cited as predicate
1Hair 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)
1 submission cite K251000 as a predicate
