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Laserscope

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
60
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K062719GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIESDecember 1, 2006
K061646LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIESJune 27, 2006
K034011GEMINI SURGICAL LASER SYSTEM & ACCESSORIESMarch 30, 2004
K024206AURA ISURGICAL LASER SYSTEM & ACCESSORIESNovember 17, 2003
K020021LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)July 2, 2002
K010834LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIESMay 21, 2001
K010284LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)May 1, 2001
K003765LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)March 6, 2001
K003147LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION)December 15, 2000
K990718ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)March 8, 2000
K990903LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)August 27, 1999
K984424AURA DYE LASER SYSTEM (ADLS)March 5, 1999
K984110LASERSCOPE COOLSPOTDecember 18, 1998
K972575800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED DELIVERY DEVICESJuly 17, 1998
K974896LASERSCOPE EL LASER SYSTEM AND ACCESSORIESMarch 27, 1998
K971843LASERSCOPE VELA ERBIUM:YAG LASER SYSTEM AND ACCESSORIESJuly 23, 1997
K971250LASERSCOPE MICROBEAM IV MICROMANIPULATORJune 30, 1997
K964818ORION SERIES SURGICAL LASER SYSTEM (Q-SWITCHED ND:YAG CONFIGURATION)June 17, 1997
K970948800 SERIES SURGICAL LASER SYSTEM AND ACCCESSORIESMay 21, 1997
K970157LASERSCOPE AUTOMATIC EYE PROTECTION FILTERApril 7, 1997