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Candela Laser Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
43
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K951033ANDELA DYNAMIC COOLING DEVICEAugust 15, 1996
K955662CANDELA Q-SWITCHED ALEXANDRITE LASERSJune 14, 1996
K955011CANDELA HCS 2000 URETHERAL WARMER CATHETERApril 3, 1996
K954872CANDELA CRYO-PROBE HOLDERFebruary 5, 1996
K954934CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASEFebruary 2, 1996
K953412CANDELA MODEL PLTL-1 LASER SYSTEMOctober 24, 1995
K953294CANDELA CRYOSYSTEM CS-5October 18, 1995
K950831ALEXLAZRMay 26, 1995
K946386CANDELA RUBY LAZE Q-SWITCHED RUBY LASERMarch 24, 1995
K950661CANDELA 10MM CIRCULAR SPOT LASER HANDPIECEMarch 10, 1995
K943292CANDELA SPTL VARIABLE PULSE/TUNABLE PULSED DYE LASERSMarch 9, 1995
K950633CANDELA URETHRAL/BLADDER SOUNDMarch 6, 1995
K950635CANDEKA DUKATIR SETSMarch 1, 1995
K950634CANDELA SHEATH SETSMarch 1, 1995
K945587CANDELA ELLIPTICAL SPOT HANDPIECEDecember 8, 1994
K940173CANDELA Q-SWITCHED ALEXANDRITE LASERDecember 7, 1994
K921995CANDELA H:ERB LASERNovember 7, 1994
K944090CANDELA ALEX LAZR Q-SWITCHED ALEXANDRITE LASERSeptember 30, 1994
K934811PLTL-1 & PLDL-1 510NM PULSED DYE LASERSSeptember 1, 1994
K942152CANDELA Q-SWITCHED, FREQUENCY DOUBLED ND;YAG LASER SYJuly 25, 1994