Aroma Grand
The subject device, AROMA GRAND is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). It utilizes a…
The subject device, AROMA GRAND is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser hand-piece.
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 | Daeju Medi Tech Engineering |
|---|---|
| FDA product code | OHT |
| Device type | Light Based Over-The-Counter Hair Removal |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| 510(k) | K211637 |
| Record published | 2022-03-11 |
| Record revised | 2024-10-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 0 to 40 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 20 to 80 % RH; Handling environment temperature 5 to 40 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.0 | 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
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.