Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Candela Laser Corp. — Predicate Candidate Screening

43 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

96 daysmedian FDA review time

329 days90th percentile

43clearances measured

K-number	Device	Applicant	Decided	Review days
K951033	ANDELA DYNAMIC COOLING DEVICE	Candela Laser Corp.	1996-08-15	528
K955662	CANDELA Q-SWITCHED ALEXANDRITE LASERS	Candela Laser Corp.	1996-06-14	185
K955011	CANDELA HCS 2000 URETHERAL WARMER CATHETER	Candela Laser Corp.	1996-04-03	154
K954872	CANDELA CRYO-PROBE HOLDER	Candela Laser Corp.	1996-02-05	104
K954934	CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE	Candela Laser Corp.	1996-02-02	98
K953412	CANDELA MODEL PLTL-1 LASER SYSTEM	Candela Laser Corp.	1995-10-24	96
K953294	CANDELA CRYOSYSTEM CS-5	Candela Laser Corp.	1995-10-18	96
K950831	ALEXLAZR	Candela Laser Corp.	1995-05-26	91
K946386	CANDELA RUBY LAZE Q-SWITCHED RUBY LASER	Candela Laser Corp.	1995-03-24	93
K950661	CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE	Candela Laser Corp.	1995-03-10	25
K943292	CANDELA SPTL VARIABLE PULSE/TUNABLE PULSED DYE LASERS	Candela Laser Corp.	1995-03-09	244
K950633	CANDELA URETHRAL/BLADDER SOUND	Candela Laser Corp.	1995-03-06	21
K950634	CANDELA SHEATH SETS	Candela Laser Corp.	1995-03-01	16
K950635	CANDEKA DUKATIR SETS	Candela Laser Corp.	1995-03-01	16
K945587	CANDELA ELLIPTICAL SPOT HANDPIECE	Candela Laser Corp.	1994-12-08	24
K940173	CANDELA Q-SWITCHED ALEXANDRITE LASER	Candela Laser Corp.	1994-12-07	330
K921995	CANDELA H:ERB LASER	Candela Laser Corp.	1994-11-07	923
K944090	CANDELA ALEX LAZR Q-SWITCHED ALEXANDRITE LASER	Candela Laser Corp.	1994-09-30	39
K934811	PLTL-1 & PLDL-1 510NM PULSED DYE LASERS	Candela Laser Corp.	1994-09-01	329
K942152	CANDELA Q-SWITCHED, FREQUENCY DOUBLED ND;YAG LASER SY	Candela Laser Corp.	1994-07-25	83
K941230	MINI-UB ENDOSCOPES	Candela Laser Corp.	1994-06-17	94
K934706	CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATU	Candela Laser Corp.	1994-04-29	211
K931762	CANDELA SPTL PULSED DYE LASERS	Candela Laser Corp.	1994-03-15	341
K933268	CANDELA GUIDEWIRE	Candela Laser Corp.	1994-02-10	219
K933016	CANDELA PLTL-1 LASER SYSTEM	Candela Laser Corp.	1994-02-09	233
K932930	CANDELA MINIBRUSH	Candela Laser Corp.	1993-10-05	112
K924158	CANDELA LASSER SYSTEMS MODIFIED	Candela Laser Corp.	1993-01-15	150
K920062	CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LAS.	Candela Laser Corp.	1992-06-05	150
K913314	CANDELA RETINAL CAMERA	Candela Laser Corp.	1992-01-23	182
K912443	CANDELA INTRODUCER SHEATH SYSTEM	Candela Laser Corp.	1991-08-16	74
K910732	CANDELA MINI-UB ENDOSCOPE	Candela Laser Corp.	1991-04-12	50
K910612	CANDELA DIODE TRABECULOPLASTY LASER DTL	Candela Laser Corp.	1991-03-04	20
K900858	CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES	Candela Laser Corp.	1990-10-03	222
K901723	MDL-2000 LASERTRIPTER	Candela Laser Corp.	1990-07-13	88
K900904	CANDELA DIRECTABLE BILIARY CATHETER SYSTEM	Candela Laser Corp.	1990-05-11	73
K893630	CANDELA UPC LASER PHOTOCOAGULATOR	Candela Laser Corp.	1989-08-02	83
K892516	CANDELA PLDL-1 PULSED DYE LASER	Candela Laser Corp.	1989-06-15	65
K885255	MDL-1 LASERTRIPTER(TM)	Candela Laser Corp.	1989-06-01	160
K884738	CANDELA STONE BASKETS	Candela Laser Corp.	1989-02-09	87
K884153	CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE	Candela Laser Corp.	1988-12-28	89
K882243	SPTL-1 PULSED DYE LASER	Candela Laser Corp.	1988-07-05	35
K880503	MDL-1 LASERTRIPTER	Candela Laser Corp.	1988-06-17	130
K874858	LASERTRIPTER MINISCOPE	Candela Laser Corp.	1988-02-19	86

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda