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Candela Laser Corp.

FDA 510(k) & PMA Approved Devices — 43 products

Total Devices43
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K951033 ANDELA DYNAMIC COOLING DEVICEIMD1996-08-15 View
510(k) K955662 CANDELA Q-SWITCHED ALEXANDRITE LASERSGEX1996-06-14 View
510(k) K955011 CANDELA HCS 2000 URETHERAL WARMER CATHETERGEH1996-04-03 View
510(k) K954872 CANDELA CRYO-PROBE HOLDERGEH1996-02-05 View
510(k) K954934 CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASEGEX1996-02-02 View
510(k) K953412 CANDELA MODEL PLTL-1 LASER SYSTEMGEX1995-10-24 View
510(k) K953294 CANDELA CRYOSYSTEM CS-5GEH1995-10-18 View
510(k) K950831 ALEXLAZRGEX1995-05-26 View
510(k) K946386 CANDELA RUBY LAZE Q-SWITCHED RUBY LASERGEX1995-03-24 View
510(k) K950661 CANDELA 10MM CIRCULAR SPOT LASER HANDPIECEGEX1995-03-10 View
510(k) K943292 CANDELA SPTL VARIABLE PULSE/TUNABLE PULSED DYE LASERSGEX1995-03-09 View
510(k) K950633 CANDELA URETHRAL/BLADDER SOUNDFBX1995-03-06 View
510(k) K950634 CANDELA SHEATH SETSDQY1995-03-01 View
510(k) K950635 CANDEKA DUKATIR SETSDQY1995-03-01 View
510(k) K945587 CANDELA ELLIPTICAL SPOT HANDPIECEGEX1994-12-08 View
510(k) K940173 CANDELA Q-SWITCHED ALEXANDRITE LASERGEX1994-12-07 View
510(k) K921995 CANDELA H:ERB LASERGEX1994-11-07 View
510(k) K944090 CANDELA ALEX LAZR Q-SWITCHED ALEXANDRITE LASERGEX1994-09-30 View
510(k) K934811 PLTL-1 & PLDL-1 510NM PULSED DYE LASERSGEX1994-09-01 View
510(k) K942152 CANDELA Q-SWITCHED, FREQUENCY DOUBLED ND;YAG LASER SYGEX1994-07-25 View
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