IPL Cooling Hair Removal Device
Shenzhen Siken 3D Technology Development 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
- K232845
- Device name
- IPL Cooling Hair Removal Device
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-09-14
- Decision date
- 2023-11-14
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- Body
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
Intended Use
IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
Device Description
The subject device IPL Cooling Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL Cooling Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. Also, the subject device is equipped with cooling function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use. There are SKB-1808, SKB-2308, SKB-2128N, and SKB-2188N four models in this application. Their work principle, function, intended use, structure, and composition are the same, with differences being product appearance, and wavelength range, also their energy outputs are slight differences, but these parameters are within the
Summary parsed at:2026-06-11 04:42:42 UTC
Predicate devices
1IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108
K232845 references 1 predicate/reference device
Cited as predicate
2IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)
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)
2 submissions cite K232845 as a predicate