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
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 |
|---|---|---|---|---|---|---|
| June 6, 2023 | K212733 | Diode laser therapy device | GEX | Substantially Equivalent | Beijing Star New Tech Co., Ltd. | accessdata.fda.gov |
| September 5, 2021 | K211736 | Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) | NUH | Substantially Equivalent | Shenzhen Osto Technology Company Limited | accessdata.fda.gov |
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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.