Realton (Suzhou) Medical Technology Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 1 device type, 3 clearances.
Realton (Suzhou) Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Powered Laser Surgical Instrument. Its earliest product listing with the FDA dates from 2021.
1device type
3510(k) clearances
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3019906161 |
| FEI number | 3019906161 |
| Establishment type | Manufacturer |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | 601 Room, B8 Building, 218 Xinghu Road, Suzhou Industrial Park, Suzhou, |
| Postal code | 215123 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | Class 2 | FLARE™ single-use surgical laser fiber, Single-use sterile medical laser fiber, Surgical Green Laser System | 2021 | 92 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K202828 | 2021-06-04 | GEX | Traditional | This company |
| K202702 | 2021-02-26 | GEX | Traditional | This company |
| K202601 | 2020-12-15 | GEX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2013 |
|---|---|
| Main products | Green Laser Surgical Systems for Benign Prostate Hyperplasia Treatment |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.