Smoothskin
15 catalogue numbers from SmoothSkin Bare Fit, listed by Cyden Ltd, United Kingdom, under Light Based Over-The-Counter Hair Removal. 69 manufacturers in China are registered for this product code.
69manufacturers in China registered for this device type
15catalogue numbers in this listing
15510(k) clearances naming this product code
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 | Cyden Ltd, United Kingdom |
|---|---|
| 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K163552 |
| Record published | 2022-01-24 |
| Record revised | 2026-01-01 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 5 to 40 °C |
| Packaging | Box of 6 |
| Distribution end date | 2026-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SmoothSkin Bare Fit | Withdrawn | |
| SmoothSkin GOLD 120k | Withdrawn | |
| SmoothSkin Bare+ | Withdrawn | |
| SmoothSkin GOLD 300k | Withdrawn | |
| SmoothSkin Bare+ | Withdrawn | |
| SmoothSkin Pure | Withdrawn | |
| SmoothSkin Pure Adapt | Withdrawn | |
| SmoothSkin Bare Fit | Withdrawn | |
| SmoothSkin Bare Fit | Withdrawn | |
| SmoothSkin Bare+ | Withdrawn | |
| SmoothSkin BARE | Withdrawn | |
| SmoothSkin Pure Fit | Withdrawn | |
| SmoothSkin Pure Adapt | Withdrawn | |
| SmoothSkin Pure Mini | Withdrawn | |
| SmoothSkin Bare+ | Withdrawn |
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 |
| 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 |
| Innza | Foshan Jindi Electric Appliance Co., Ltd. | 7 |
Showing 12 of 75. All products under Light Based Over-The-Counter Hair Removal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243362 | 2024-11-27 |
| K240587 | 2024-03-29 |
| K233782 | 2023-12-20 |
| K230911 | 2023-04-27 |
| K213692 | 2022-01-26 |
| K211994 | 2021-07-28 |
| K200184 | 2020-02-21 |
| K192010 | 2019-09-24 |
| K190354 | 2019-03-18 |
| K190366 | 2019-03-18 |
| K163552 | 2017-03-03 |
| K162231 | 2016-11-16 |
| K160968 | 2016-04-14 |
| K130315 | 2013-07-12 |
| K122280 | 2012-10-23 |
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.