Beijing Winkonlaser Technology Limited
Registered establishment in Beijing, China. 14 device types, 2 clearances.
Beijing Winkonlaser Technology Limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Gas, Laser Generating, Powered Microneedle Device and 12 other device types. Its earliest product listing with the FDA dates from 2022.
Registration
| Registered name | BEIJING WINKONLASER TECHNOLOGY LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015452693 |
| FEI number | 3015452693 |
| Establishment type | Contract manufacturer, Private-label distributor, Manufacturer, Exporter |
Location
| City | Beijing |
|---|---|
| Province | Beijing |
| Address | No.28,Hegezhuang,Xiji Town,Tongzhou Dist. |
| Postal code | 101108 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue | Class N | High Intensity Focus Ultrasound (HIFU) System | 2022 | 4 |
| Brush, Dermabrasion, Powered | Class 1 | Aqua Facial Hydrogen Oxygen Bubble System | 2022 | 65 |
| Device, Skin Potential Measurement | Class 2 | Skin Analyzer System | 2022 | 6 |
| Gas, Laser Generating | Class 1 | CO2 Fractional Laser System | 2022 | 17 |
| Laser, Cellulite Appearance | Class 2 | laser, cellulite appearance – Cryolipolysis Beauty System | 2022 | 2 |
| Light Based Over-The-Counter Hair Removal | Class 2 | Long Pulse Alexandrite Laser System, IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) | 2022 | 69 |
| Massager, Vacuum, Radio Frequency Induced Heat | Class 2 | Radio frequency and vacuum machine | 2024 | 13 |
| Powered Laser Surgical Instrument | Class 2 | IPL DPL SHR Elight Therapy Machine, Long Pulse Nd: YAG Laser System, Diode Laser Hair Removal System, Diode Laser Hair Removal System falcon 4 pro, Nd:YAG Laser Picosecond Laser System, CO2 Fractional Laser and 1 more | 2022 | 92 |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | Class 2 | CO2 Fractional Laser | 2026 | 12 |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | Class 2 | Elight System; IPL; SHR | 2022 | 31 |
| Powered Microneedle Device | Class 2 | Microneedle Fractional RF System | 2022 | 10 |
| Powered Surgical Instrument For Improvement In The Appearance Of Cellulite | Class 2 | HIFEM Beauty System | 2022 | 6 |
| Stimulator, Muscle, Powered | Class 2 | Electronic Muscle Stimulator | 2024 | 33 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | High Intensity Focused Electromagnetic Stimulation Device | 2026 | 66 |
Clearances
2 clearances name Beijing Winkonlaser Technology Limited as applicant. 4 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253790 | 2026-08-13 | NGX | Traditional | This company |
| K241860 | 2024-09-25 | GEX | Traditional | This company |
| K233007 | 2024-06-12 | GEX | Traditional | AMI Inc. |
| K221246 | 2022-07-07 | OHT | Traditional | Shenzhen Semlamp Intelligent Technology Co., Ltd. |
| K182663 | 2018-11-30 | GEX | Traditional | Finemec Co., Ltd. |
| K162169 | 2016-10-27 | GEX | Traditional | Jeisys Medical Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2012 |
|---|---|
| Main products | Diode laser hair removal, HIFU lifting systems, Cryolipolysis machines, EMS sculpting, RF machines |
| Certifications | ISO13485, CE, FDA |
| Export markets | 120+ countries with strategic warehouses in China, USA, France, Turkey |
| OEM and ODM | Offered |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.