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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

DeviceProduct codeClassRoleSource
Apparatus, RollerKJB1Exporter to the US, Manufactureraccessdata.fda.gov
Energy Based Device For Treatment Of TattoosQHF2Exporter to the US, Manufactureraccessdata.fda.gov
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot UlcersPZL2Exporter to the US, Manufactureraccessdata.fda.gov
Gas, Laser GeneratingNXF1Exporter to the US, Manufactureraccessdata.fda.gov
Laser Assisted LipolysisORK2Exporter to the US, Manufactureraccessdata.fda.gov
Light Based Over-The-Counter Hair RemovalOHT2Exporter to the US, Manufactureraccessdata.fda.gov
Marker, SkinFZZ1Exporter to the US, Manufactureraccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Exporter to the US, Manufactureraccessdata.fda.gov
Powered Laser Surgical Instrument With MicrobeamFractional OutputONG2Exporter to the US, Manufactureraccessdata.fda.gov
Powered Microneedle DeviceQAI2Exporter to the US, Manufactureraccessdata.fda.gov
Powered Surgical Instrument For Improvement In The Appearance Of CelluliteOUP2Exporter to the US, Manufactureraccessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle ConditioningNGX2Exporter to the US, Manufactureraccessdata.fda.gov

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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 17, 2024K242186Neo Sculptor (OF-NEO001)NGXSubstantially EquivalentOfan Intelligent Technology (Guangzhou) Co. , Ltd.accessdata.fda.gov
December 7, 2017K172908Q-Switched Nd:YAG Laser SystemGEXSubstantially EquivalentAmi, Inc.accessdata.fda.gov
July 6, 2017K162398CO2 Laser Therapy SystemsONGSubstantially EquivalentBeijing Sincoheren Science and Technology Development Co.accessdata.fda.gov
June 16, 2017K162659Diode Laser Hair Removal SystemGEXSubstantially EquivalentShandong Huamei Technology Co., Ltd.accessdata.fda.gov

Compare with other makers

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.