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Data / Medical devices / China / Beijing Spiritlaser Science & Technology Co., Ltd.

Beijing Spiritlaser Science & Technology Co., Ltd.: FDA-registered device maker in Beijing, China, 2 510(k) clearances

Beijing Spiritlaser Science & Technology Co., Ltd. is registered with the FDA (registration 3017132875) in Beijing, China. It lists 21 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 6, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3017132875
Address
2-813, Floor 8, Building 1, Yard 56, Fuqian Street, Beijing, China, 101300
Owner or operator
Beijing Spiritlaser Science & Technology Co., Ltd. (10092055)
Roles
Contract manufacturer, Exporter to the US, Manufacturer
First device listed
November 28, 2024
Registered through
2026
Brand names listed
Cavitation Lipolaser vacuum system machine, Co2 Fractional Laser, Cryolipolysis Slimming Machine, Dermatological Diode Laser Systems, Diode laser therapy device, ELECTRONIC MUSCLE STIMULATOR, EMS SCULPTING, EMS face machine and more

Devices it lists

DeviceProduct codeClassRoleSource
Ablation System, High Intensity Focus Ultrasound (Hifu), Soft TissuePZCNExporter to the USaccessdata.fda.gov
Brush, Dermabrasion, PoweredGFE1Exporter to the USaccessdata.fda.gov
Colorimeter, Photometer, Spectrophotometer For Clinical UseJJQ1Exporter to the USaccessdata.fda.gov
Dermal Cooling Pack/Vacuum/MassagerOOK2Manufactureraccessdata.fda.gov
Device, Skin Potential MeasurementHCJ2Exporter to the USaccessdata.fda.gov
Energy Based Device For Treatment Of TattoosQHF2Exporter to the USaccessdata.fda.gov
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot UlcersPZL2Exporter to the USaccessdata.fda.gov
Fat Reducing Low Level LaserOLI2Exporter to the USaccessdata.fda.gov
Gas, Laser GeneratingNXF1Exporter to the USaccessdata.fda.gov
Light Based Over-The-Counter Hair RemovalOHT2Manufactureraccessdata.fda.gov
Marker, SkinFZZ1Manufactureraccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Exporter to the USaccessdata.fda.gov
Massager, Vacuum, Light Induced HeatingNUV2Exporter to the USaccessdata.fda.gov
Over-The-Counter Radiofrequency Coagulation Device For Wrinkle ReductionPAY2Manufactureraccessdata.fda.gov
Pen, Marking, SurgicalHRP1Manufactureraccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Contract manufacturer, Manufactureraccessdata.fda.gov
Powered Laser Surgical Instrument With MicrobeamFractional OutputONG2Exporter to the USaccessdata.fda.gov
Powered Microneedle DeviceQAI2Exporter to the USaccessdata.fda.gov
Powered Surgical Instrument For Improvement In The Appearance Of CelluliteOUP2Exporter to the USaccessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle ConditioningNGX2Contract manufacturer, Manufactureraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-CounterNUH2Manufactureraccessdata.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
June 6, 2023K212733Diode laser therapy deviceGEXSubstantially EquivalentBeijing Star New Tech Co., Ltd.accessdata.fda.gov
September 5, 2021K211736Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)NUHSubstantially EquivalentShenzhen Osto Technology Company Limitedaccessdata.fda.gov

Compare with other makers

Updated June 6, 2023. 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.