Beijing Syntech Laser Co., Ltd
FDA Regulatory Profile
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 3
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1490-2018 | Class II | Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers | July 3, 2017 |
| Z-1495-2018 | Class II | Beijing Syntech Laser UL Station surgical lasers | July 3, 2017 |
| Z-1493-2018 | Class II | Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers | July 3, 2017 |
| Z-1494-2018 | Class II | Beijing Syntech Laser Nice Station Light Based Platform surgical lasers | July 3, 2017 |
| Z-1489-2018 | Class II | Beijing Syntech Laser Trixel C02 Laser surgical lasers | July 3, 2017 |
| Z-1492-2018 | Class II | Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers | July 3, 2017 |
| Z-1491-2018 | Class II | Beijing Syntech Laser UL C02 Laser surgical lasers | July 3, 2017 |
| Z-1488-2018 | Class II | Beijing Syntech Laser Diode Laser surgical lasers | July 3, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K123483 | DIODE LASER | April 21, 2013 |
| K113018 | APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM | December 14, 2012 |
| K110434 | TRIXEL CO2 LASER | April 19, 2011 |