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Sharplan Lasers, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
78
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K973354SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)December 4, 1997
K972099SHARPLAN EPITOUCH RUBY LASER SYSTEMAugust 27, 1997
K971874SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)August 18, 1997
K971648SHARPLAN ERBIUM: YAG LASER (4020)July 23, 1997
K971743SHARPLAN CO2 SURGICAL LASER SYSTEMJuly 18, 1997
K962446SHARPLAN RUBY LASER SYSTEMMarch 7, 1997
K963229SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERSNovember 5, 1996
K961935SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNERNovember 1, 1996
K962974SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713)August 21, 1996
K961279SHARPLAN LASERS, INC. RUBY LASER SYSTEMJune 18, 1996
K960820SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNERMay 10, 1996
K960040SHARPLAN ULTRA LAPAROSCOPIC HANDPIECEApril 29, 1996
K960521SHARPLAN LASERS, INC. SILKTOUCH FLASH SCANNERApril 26, 1996
K955621SHARPLAN LASERS, INC SILKTOUCH 2 FLASH SCANNERFebruary 27, 1996
K952277SHARPLAN MODEL 2040 PULSED CTH:YAG SURGICAL LASER SYSTEMNovember 16, 1995
K953794SHARPLAN LASERS, INC. SURGICAL DIODE LASERNovember 14, 1995
K951165SHARPLAN MODEL 3100 ND:YAG SURGICAL LASER SYSTEMJune 12, 1995
K951204SHARPLAN MODEL 712 ACUSPOT MICROMANIPULATORJune 1, 1995
K945796SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEMMay 24, 1995
K950725SHARPLAN MODEL 1015 CO2 LASERApril 6, 1995