Data / Medical devices / China / Realton (Suzhou) Medical Technology Co., Ltd.
Realton (Suzhou) Medical Technology Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 3 510(k) clearances
Realton (Suzhou) Medical Technology Co., Ltd. is registered with the FDA (registration 3019906161) in Suzhou Jiangsu, China. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated June 4, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3019906161
- Address
- 601 Room, B8 Building, 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Suzhou Jiangsu, China, 215123
- Owner or operator
- Realton (Suzhou) Medical Technology Co., Ltd. (10082212)
- Roles
- Manufacturer
- First device listed
- June 29, 2021
- Registered through
- 2026
- Brand names listed
- FLARE single-use surgical laser fiber, Single-use sterile medical laser fiber, Surgical Green Laser System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| June 4, 2021 | K202828 | Surgical Green Laser System | GEX | Substantially Equivalent | Realton (Suzhou) Medical Technology Co., Ltd. | accessdata.fda.gov |
| February 26, 2021 | K202702 | FLARE Single-Use Surgical Laser Fiber | GEX | Substantially Equivalent | Realton (Suzhou) Medical Technology Co., Ltd. | accessdata.fda.gov |
| December 15, 2020 | K202601 | Single-use Sterile medical laser fiber | GEX | Substantially Equivalent | Realton (Suzhou) Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 4, 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.