Data / Medical devices / China / Ivylaser (beijing) Technology Co., Ltd.
Ivylaser (beijing) Technology Co., Ltd.: FDA-registered device maker in Beijing, China, 3 510(k) clearances
Ivylaser (beijing) Technology Co., Ltd. is registered with the FDA (registration 3013446079) in Beijing, China. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 24, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013446079
- Address
- Room 411, Building 3, No. 2 Shengfang Road, Daxing District, Beijing, Beijing, China, 102600
- Owner or operator
- Ivylaser (Beijing) Technology Co., Ltd. (10088367)
- Roles
- Manufacturer
- First device listed
- July 10, 2023
- Registered through
- 2026
- Brand names listed
- Diode laser system(Night Universe), Diode laser system(Predator), IVYLASER Diode laser hair removal system(IVY-HR-Alloy), IVYLASER Handhold Hair Removal Machine
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light Based Over-The-Counter Hair Removal | OHT | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 24, 2025 | K250206 | Diode laser system (Night Universe; Predator) | GEX | Substantially Equivalent | Ivylaser (Beijing) Technology Co.,Ltd | accessdata.fda.gov |
| June 20, 2024 | K240611 | IVYLASER Diode laser hair removal system (IVY-HR-Alloy) | GEX | Substantially Equivalent | Ivylaser (Beijing) Technology Co.,Ltd | accessdata.fda.gov |
| July 3, 2023 | K230025 | IVYLASER Handhold Hair Removal Machine | OHT | Substantially Equivalent | Ivylaser (Beijing) Technology Co.,Ltd | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Light Based Over-The-Counter Hair Removal
Updated April 24, 2025. 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.