Hand-Held IPL Device (IPL Home Use Hair Removal Device)
This handheld device uses intense pulsed light to remove unwanted hair and reduce subsequent hair regrowth. It is intended for personal use at home and is available over the counter. A…
This handheld device uses intense pulsed light to remove unwanted hair and reduce subsequent hair regrowth. It is intended for personal use at home and is available over the counter. A handheld applicator connected to an external power supply delivers light through a treatment window covering three square centimetres.
A skin proximity sensor checks contact at the treatment area. The device will not emit a pulse unless the applicator is fully against the skin. The user triggers pulses with a finger switch, and the light is supplied by a xenon arc flashlamp.
Energy Settings
FZ-608, FZ-608G and FZ-100 have nine output levels. FZ-200 has six. The output ranges and required power adapters differ between models.
Who Else Makes It
Concentrated in Guangdong (52), Beijing (5), Hebei (3). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Xiazhifeng Electronic Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 25 |
| Shenzhen Jie Zhong Lian Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Xiamen Solex High-Tech Industries Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 9 |
| Zhangzhou Easepal Medical Science AND Technology Co., Ltd. | Zhangzhou | Fujian | Contract manufacturer | 8 |
| Shenzhen Zowee Smart Manufacturing Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Dongguan Define Beauty Electronic Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 5 |
| Shen Zhen HanShine Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Dongguan Jiacom Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Guangzhou Telefield Limited | Guangzhou | Guangdong | Contract manufacturer | 3 |
| Shenzhen Huachuangtong Industrial Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Shenzhen JVK Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Shenzhen Eyco Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 27 |
Showing 12 of 69. All 69 manufacturers in China registered for Light Based Over-The-Counter Hair Removal
Record
| Listed by | Shenzhen Ionka Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | OHT |
| Device type | Light Based Over-The-Counter Hair Removal |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Manufacturer |
| 510(k) | K230739 |
| Record published | 2023-08-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FZ-100 | In distribution | |
| FZ-608G | In distribution | |
| FZ-200 | In distribution | |
| FZ-608 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ulike | Shenzhen Ulike Smart Electronics Co., Ltd. | 212 |
| IPL Home Use Hair Removal Device | Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. | 41 |
| IPL Home Use Hair Removal Device | Dongguan Letme Medical Technology Co., Ltd. | 29 |
| Mlay | Shenzhen Mlay Intelligent Technology Co., Ltd. | 26 |
| semlamp | Shenzhen Semlamp Intelligent Technology Co., Ltd. | 20 |
| Intense Pulsed Light (IPL) System | Shenzhen Fansizhe Science AND Technology Co., Ltd. | 18 |
| Smoothskin | Cyden Ltd | 15 |
| Pakiss | Shenzhen Xiazhifeng Electronic Co., Ltd. | 13 |
| Mustbeaty | Mustech Electronics Co., Limited | 12 |
| Jianchao Smart | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 12 |
| Jovs Hair Removal Device | Shenzhen Qianyu Technology Co., Ltd. | 10 |
| Silk’n | Home Skinovations, Ltd. | 8 |
Showing 12 of 75. All products under Light Based Over-The-Counter Hair Removal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230739 | 2023-05-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.