Sensilight Pro – Bronze
Sensilight Pro is an over-the-counter intense pulsed light device for removing unwanted body or facial hair in adults. It is also intended to reduce hair regrowth over time. The hand-held…
Sensilight Pro is an over-the-counter intense pulsed light device for removing unwanted body or facial hair in adults. It is also intended to reduce hair regrowth over time. The hand-held applicator delivers light energy that targets hair through selective photothermolysis.
The system includes the applicator and an external power supply or charger. Large and precision treatment windows provide areas of 4.5 and 2 square centimeters. A lamp generates the treatment pulses, while sensors check skin proximity and pigmentation before a pulse can be delivered.
Listed Item
The Sensilight Pro is an over-the-counter device intended for the removal of unwanted body and/or facial hair. Sensilight Pro is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured 6, 9 and 12 months after the completion of treatment regimen.
Skin Contact Controls
Treatment requires full contact with compatible skin tones. The device indicates improper contact or excessively dark or tanned skin and prevents pulse delivery under those conditions. Permanent reduction refers to stable reduction in regrowth measured six, nine and twelve months after completing treatment.
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 | EL Global Trade Ltd., Israel |
|---|---|
| FDA product code | OHT |
| Device type | Light Based Over-The-Counter Hair Removal |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K183260 |
| Record published | 2020-11-08 |
| Record revised | 2021-10-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPL300US04SNS | 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 |
|---|---|
| K250384 | 2025-05-23 |
| K183260 | 2019-03-18 |
| K172181 | 2017-10-13 |
| K161089 | 2016-07-08 |
| K140381 | 2014-08-08 |
| K140527 | 2014-07-31 |
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.