Data / Medical devices / China / Lightstone Medical Products (ningbo) Co Ltd
Lightstone Medical Products (ningbo) Co Ltd: FDA-registered device maker in Ningbo Zhejiang, China, 1 510(k) clearance
Lightstone Medical Products (ningbo) Co Ltd is registered with the FDA (registration 3016170302) in Ningbo Zhejiang, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 30, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016170302
- Address
- Room 4-8, Building 61, No. 99 Jiangbei Ave Jiangbei District, Ningbo Zhejiang, China, 315032
- Owner or operator
- Lightstone Medical Products (Ningbo) Co Ltd (10061564)
- Roles
- Specification developer
- First device listed
- October 29, 2019
- Registered through
- 2026
- Brand names listed
- Tzoar 207 Negative Pressure Wound Therapy (NPWT) System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Hydrophilic | NAC | 1 | Specification developer | accessdata.fda.gov |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | Specification developer | accessdata.fda.gov |
| Syringe, Ent | KCP | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| December 30, 2021 | K202898 | Tzoar 207 Negative Pressure Wound Therapy (NPWT) System | OMP | Substantially Equivalent | Lightstone Medical Products (Ningbo) Co, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Hydrophilic
- All makers of Syringe, Ent
- All makers of Negative Pressure Wound Therapy Powered Suction Pump
Updated December 30, 2021. 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.