510(k) · Cleared

Cleared

Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems

K063073510(k) TraditionalCleared Dec 20, 200675-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Candela Corp. · GEX Powered Laser Surgical Instrument

Cleared on Dec 20, 2006 as substantially equivalent to K955662 (Candela Laser Corp., 1996) and 1 other predicate after a 75-day review. Its family tree reaches back 1 generation to 1995. 114 later devices descend from it.

Decided: Dec 20, 2006
Review: 75 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K950831 (1995). 2 ancestors in all. 114 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK950831 AlexlazrCandela Laser Corp. · 1995
This deviceK063073 Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp. · 2006
Descendant · cites it directly · 113 of its ownK073534 Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp. · 2008
Descendant · 2 generations on · 112 of its ownK081324 Candela Family of Q-Switched Alexandrite LasersCandela Corp. · 2008
Descendant · 3 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Descendant · 4 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
Descendant · 5 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015

Showing 5 of 114 descendants. See all descendants

Descendants cleared per year

2008high 18 (2022) · low 0 (2009)2026

Most influential descendants

Showing 5 of 114 · See all

K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp. · 2008 · cites it directly113descendants
K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp. · 2008 · 2 generations on112descendants
K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 3 generations on111descendants
K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 4 generations on70descendants
K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 5 generations on62descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K950831	Alexlazr	Candela Laser Corp.	1995	—
0 (this device)	K063073	Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems	Candela Corp.	2006	—
+1	K073534	Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems	Candela Corp.	2008	—
+2	K081324	Candela Family of Q-Switched Alexandrite Lasers	Candela Corp.	2008	—
+3	K101916	Joule Multi-Platform System	Sciton, Inc	2011	—
+4	K132806	Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece	Fotona D.D.	2014	—
+5	K143723	SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro	Fotona D.D.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	2	0
2011	1	0
2014	3	0
2015	5	0
2016	1	0
2017	4	0
2018	8	0
2019	6	0
2020	11	0
2021	8	0
2022	18	0
2023	9	0
2024	13	0
2025	14	0
2026	11	0

FIG. 1 — Lineage of K063073, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEX device

#1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K955662	Candela Q-Switched Alexandrite Lasers Summary page 1 …21 CFR § 878.481 0 Device Classification: II Identification of Predicate Device Predicate Device(s): Candela Q-Switched Alexandrite Laser (AlexL~R), K955 662 Candela Q-Switched Alexandrite Laser (AleXLAR), K(950831 Device Description The Candela Family o…	Candela Laser Corp.	1996	—
*	K950831	Alexlazr Summary page 2 …s is substantial equivalent to the currently legally marketed Candela Q-Switched Alexandrite Laser, (AlexLAzR), K955662, Candela Q-Switched Alexandrite Laser (AlexL~zR), K950831 predicate devices in intended use and technological features and therefore the risks and benefits are comparable to the predicate…	Candela Laser Corp.	1995	—

Also cleared against K955662: 2 other devices →

What descends from it? (114)

See all 114

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K073534	Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems	Candela Corp.	2008	113

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K073534 (Candela Corp., 2008) has gone furthest, with 113 descendants of its own.
2 other devices also cite its predicate K955662.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	73	79	9	342
2008	107	86	2	232
2009	69	100	0	209
2010	50	96	4	1,711
2011	41	83	18	3,024
2012	45	118	5	2,000
2013	46	144	3	2,236
2014	61	147	6	2,036
2015	47	112	0	2,099
2016	51	114	1	2,585
2017	67	90	5 (1)	2,977
2018	51	78	5	3,525
2019	41	88	6	2,709
2020	52	90	1	2,183
2021	53	123	0	3,465
2022	60	152	0	2,288
2023	52	87	6	2,337
2024	82	90	3	2,187
2025	83	90	0	2,720
2026	57	90	2	—

What is it indicated for?

The Candela Family of Q-Switched Alexandrite Laser (AlexLTzR) systems is indicated for

the following uses:

Pigmented Lesions

Tattoos

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063073 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063073: Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063073

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026