Data / Medical devices / China / Ziree (Shenzhen) Medical Technology Co.,Ltd
Ziree (Shenzhen) Medical Technology Co.,Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Ziree (Shenzhen) Medical Technology Co.,Ltd is registered with the FDA (registration 3031191551) in Shenzhen Guangdong, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 26, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031191551
- Address
- 14F T10 Bldg.,Sino-Ocean New World,Longcheng Street,Longgang District, Shenzhen Guangdong, China, 518172
- Owner or operator
- Ziree (shenzhen) Medical technology Co.,Ltd. (10090456)
- Roles
- Manufacturer
- First device listed
- March 31, 2024
- Registered through
- 2026
- Brand names listed
- (HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5), CO2 Fractional Laser System, Lipo Laser System, Light Based Over The Counter Wrinkle Reduction,, Gynecological Therapy Device for Vaginal Health, PDT Photon skin rejuvenation,, Infrared Light Skin Care Device, Blue Light Skin Care Device, Laser Hair Growth Devices, LED Light Beauty Device,, LED Face Mask,Red Infrared Light Therapy Gloves,, LED Light Skin Rejuvenation Device, Low Energy Laser Health Support Device,, LED Red Light Therapy for Feet & Body, Skin Health UV Lamp ,UVB Light Therapy, 308nm Phototherapy Device,, Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Laser, Comb, Hair | OAP | 2 | Manufacturer | accessdata.fda.gov |
| Light, Wood'S, Fluorescence | GMB | 1 | 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 |
|---|---|---|---|---|---|---|
| June 26, 2026 | K261253 | Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5) | OAP | Substantially Equivalent | Ziree Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Light, Wood'S, Fluorescence
- All makers of Laser, Comb, Hair
- All makers of Lamp, Infrared, Therapeutic Heating
Updated June 26, 2026. 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.