Beijing Syntech Laser Co., Ltd

FDA Regulatory Profile

Beijing Syntech Laser Co., Ltd appears in FDA public data with 8 recalls, 3 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1493-2018, Class II) was initiated on July 3, 2017. Its most recent 510(k) clearance was granted on April 21, 2013.

Summary

Total Recalls
8
510(k) Clearances
3
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1493-2018Class IIBeijing Syntech Laser APOLLO JV+ Medical Platform surgical lasersJuly 3, 2017
Z-1490-2018Class IIBeijing Syntech Laser Trixel 11 C02 Laser surgical lasersJuly 3, 2017
Z-1492-2018Class IIBeijing Syntech Laser APOLLO V+ Medical Platform surgical lasersJuly 3, 2017
Z-1488-2018Class IIBeijing Syntech Laser Diode Laser surgical lasersJuly 3, 2017
Z-1491-2018Class IIBeijing Syntech Laser UL C02 Laser surgical lasersJuly 3, 2017
Z-1495-2018Class IIBeijing Syntech Laser UL Station surgical lasersJuly 3, 2017
Z-1489-2018Class IIBeijing Syntech Laser Trixel C02 Laser surgical lasersJuly 3, 2017
Z-1494-2018Class IIBeijing Syntech Laser Nice Station Light Based Platform surgical lasersJuly 3, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K123483DIODE LASERApril 21, 2013
K113018APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORMDecember 14, 2012
K110434TRIXEL CO2 LASERApril 19, 2011