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

Candela Corp. — Predicate Candidate Screening

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

88 daysmedian FDA review time

195 days90th percentile

48clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K183452	Vbeam Prima Laser System	Candela Corp.	2019-02-01	50	0
K140732	CANDELA GENTLELASE FAMILY OF LASER SYSTEMS	Candela Corp.	2014-11-07	228	0
K140122	CANDELA GENTLEMAX FAMILY OF LASER SYSTEM	Candela Corp.	2014-05-09	113	0
K133283	CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS	Candela Corp.	2013-12-26	62	0
K112715	CANDELA GENTLEMAX FAMILY OF LASERS	Candela Corp.	2011-10-05	16	0
K111144	CANDELA GENTLELASE FAMILY OF LASERS	Candela Corp.	2011-07-18	87	0
K081324	CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS	Candela Corp.	2008-06-17	36	0
K073534	CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SY	Candela Corp.	2008-04-03	108	0
K071469	INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM	Candela Corp.	2007-08-15	78	0
K063800	CANDELA FLUORESCENT PULSED LIGHT SYSTEM	Candela Corp.	2007-02-05	45	0
K063074	CANDELA 3630 LASER SYSTEM	Candela Corp.	2006-12-27	82	0
K063073	CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SY	Candela Corp.	2006-12-20	75	0
K063072	CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SY	Candela Corp.	2006-12-20	75	0
K051359	CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION	Candela Corp.	2005-07-13	50	1
K050673	CANDELA FAMILY OF PULSE DYE LASER SYSTEMS	Candela Corp.	2005-06-13	90	2
K043251	CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CB	Candela Corp.	2005-02-09	78	0
K041242	CANDELA SMOOTHBEAM LASER SYSTEM	Candela Corp.	2004-11-22	195	0
K033461	CANDELA VBEAM PULSE DYE LASER SYSTEM	Candela Corp.	2004-01-16	78	0
K033331	CANDELA CBEAM PULSE DYE LASER SYSTEM	Candela Corp.	2004-01-16	92	0
K030834	CANDELA SMOOTHBEAM LASER SYSTEM	Candela Corp.	2003-12-03	261	1
K033172	CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS	Candela Corp.	2003-10-30	30	0
K030846	CANDELA SMOOTHBEAM LASER SYSTEM	Candela Corp.	2003-09-16	183	1
K024371	CANDELA GENTLE LASE FAMILY OF LASER SYSTEM	Candela Corp.	2003-03-31	90	0
K024260	CANDELA GENTLELASE FAMILY OF LASER SYSTEMS	Candela Corp.	2003-03-21	88	1
K022923	CANDELA GENTLE YAG LASER SYSTEM	Candela Corp.	2003-03-13	190	0
K024335	CANDELA GENTLELASE FAMILY OF LASER SYSTEMS	Candela Corp.	2003-03-12	75	1
K022951	CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG	Candela Corp.	2003-01-27	144	0
K022884	CANDELA SMOOTHBEAM LASER SYSTEM	Candela Corp.	2003-01-22	145	1
K023193	CANDELA GENTLE YAG LASER SYSTEM	Candela Corp.	2002-12-20	86	0
K014128	CANDELA SMOOTHBEAM LASER SYSTEM	Candela Corp.	2002-10-04	291	0
K021180	CANDELA VBEAM PULSED DYE LASER SYSTEM	Candela Corp.	2002-07-02	78	0
K020958	CANDELA CBEAM PULSED DYE LASER SYSTEM	Candela Corp.	2002-06-21	88	0
K013825	CANDELA SMOOTHBEAM LASER SYSTEM	Candela Corp.	2002-02-15	88	1
K013748	CANDELA SCLERO LONG PULSE LASER (AKA VBEAM)	Candela Corp.	2002-02-11	90	0
K013043	CANDELA CLEARBEAM PULSED DYE LASER	Candela Corp.	2001-10-11	31	0
K011092	CANDELA SPTL-1E PULSED DYE LASER	Candela Corp.	2001-07-09	90	0
K010104	CANDELA LONG PULSE ND:YAG	Candela Corp.	2001-04-11	89	0
K002421	CANDELA MID IR DIODE LASER SYSTEM	Candela Corp.	2000-11-03	87	0
K001093	CANDELA SPTL-1B PULSED DYE LASER	Candela Corp.	2000-09-19	168	0
K001589	CANDELA DYNAMIC COOLING DEVICE	Candela Corp.	2000-08-18	87	0
K994260	CANDELA GENTLELASE GL DERMATOLOGICAL LASER	Candela Corp.	2000-05-26	161	0
K993671	CANDELA SCLERO LONG PULSE DYE LASER	Candela Corp.	2000-01-24	84	0
K984601	CANDELA GENTLELASE II DERMATOLOGICAL LASER	Candela Corp.	1999-02-04	38	0
K981351	CANDELA GENTLELASE GL DERMATOLOGICAL LASER	Candela Corp.	1998-07-13	90	0
K974381	CANDELA GENTLELASE GL DERMATOLOGICAL LASER	Candela Corp.	1998-02-10	82	0
K972767	CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER	Candela Corp.	1997-12-04	133	1
K863642	CANDELA MODEL MDL-1 LASER LITHOTRIPTOR	Candela Corp.	1986-12-03	77	0
K861179	CANDELA MODEL SPT-1, PULSED DYE LASER	Candela Corp.	1986-11-20	234	0

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