Hgm Medical Laser Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K921300MODEL PC ARGON ION LASEROctober 6, 1992
K914484LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPEJanuary 6, 1992
K913569COMPAC A, ELITE A, ELITE A PLUS, SURGICA AOctober 17, 1991
K912628AIR ARGON ION LASERS VARIOUS MODELSSeptember 13, 1991
K910272HGM COMBINATION ND:YAG & SOLID STATE GREENAugust 9, 1991
K912438MODELS 5,8,20,20S ARGON ION LASERSJuly 17, 1991
K910602HGM ARGON ION & SOLID LIGHT LASER FOR DENTISTRYJune 24, 1991
K911104PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1June 11, 1991
K910898SURGICA(TM) HMay 31, 1991
K904699COMPAC(TM) DIODE LASERSApril 25, 1991
K904700ENDOCOAGULATOR KRS568(TM) LASERFebruary 19, 1991
K904342SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20ADecember 19, 1990
K9022585 MM IRRIGATION/ASPIRATION FIBER PROBESeptember 19, 1990
K896314ENDOSCOPIC USES OF THE ARGON LASER IN GENERAL SURGMay 10, 1990
K901021F300 SERIES CONTACT FIBER HANDPIECESApril 13, 1990
K881507ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIESApril 27, 1989
K890787O-020 LASER INDIRECT OPHTHALMOSCOPEMarch 24, 1989
K881940MODEL 20 KY KRYPTON YELLOW LASERJuly 20, 1988