Data / Medical devices / China / Beijing Perfectlaser Technology Co.,ltd
Beijing Perfectlaser Technology Co.,ltd: FDA-registered device maker in Beijing, China, 4 510(k) clearances
Beijing Perfectlaser Technology Co.,ltd is registered with the FDA (registration 3023808190) in Beijing, China. It lists 12 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 17, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023808190
- Address
- A1-1001, Yanjingzongbujidi, Yanjia O Area, Beijing, China, 100000
- Owner or operator
- Beijing Perfectlaser Technology Co.,Ltd (10085539)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- June 30, 2022
- Registered through
- 2026
- Brand names listed
- ,Z950,Z900,Z940,Z940Pro,W960A,W970 ,Cavitation Slimming System,CV40C1,CV40K1,, CO2 Fractional Laser System,Z121,Z131,Z131pro,Z190,Z190A, CO2 Laser Therapy SystemsZ131,Z131Pro,Z100,Z121,Z190,Z190A, CV80Y1,Velashape Body Shaping System,Z700pro,Z700, Diode Laser Hair Removal System,Z820,Z860,Z840,Z870,Z890,, Diode Laser Hair Removal System,Z890B,Z890C,Z890E, Hydrogen Oxygen Small Bubble System,Z400,, Lipo Laser System,W100C,W180,W180A and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 17, 2024 | K242186 | Neo Sculptor (OF-NEO001) | NGX | Substantially Equivalent | Ofan Intelligent Technology (Guangzhou) Co. , Ltd. | accessdata.fda.gov |
| December 7, 2017 | K172908 | Q-Switched Nd:YAG Laser System | GEX | Substantially Equivalent | Ami, Inc. | accessdata.fda.gov |
| July 6, 2017 | K162398 | CO2 Laser Therapy Systems | ONG | Substantially Equivalent | Beijing Sincoheren Science and Technology Development Co. | accessdata.fda.gov |
| June 16, 2017 | K162659 | Diode Laser Hair Removal System | GEX | Substantially Equivalent | Shandong Huamei Technology Co., Ltd. | accessdata.fda.gov |
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Updated September 17, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.