510(k) · Cleared

Cleared

Alexlazr

K950831510(k) TraditionalCleared May 26, 199591-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 Laser Corp. · GEX Powered Laser Surgical Instrument

Cleared on May 26, 1995 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 116 later devices descend from it.

Decided: May 26, 1995
Review: 91 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

116 later devices descend from it, 2 citing it directly.

This deviceK950831 AlexlazrCandela Laser Corp. · 1995
Descendant · cites it directly · 114 of its ownK063073 Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp. · 2006
Descendant · 2 generations on · 113 of its ownK073534 Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp. · 2008
Descendant · 3 generations on · 112 of its ownK081324 Candela Family of Q-Switched Alexandrite LasersCandela Corp. · 2008
Descendant · 4 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Descendant · 5 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014

Showing 5 of 116 descendants. See all descendants

Descendants cleared per year

1998high 18 (2022) · low 0 (1999)2026

Most influential descendants

Showing 5 of 116 · See all

K063073Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp. · 2006 · cites it directly114descendants
K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp. · 2008 · 2 generations on113descendants
K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp. · 2008 · 3 generations on112descendants
K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 4 generations on111descendants
K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 5 generations on70descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2006	1	0
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 K950831, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (116)

See all 116

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K063073	Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems	Candela Corp.	2006	114
K980710	Schwartz Electro-Optics, Inc. Crystalase 755 DP Alexandrite Laser System	Schwartz Electro-Optics, Inc.	1998	0

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?

Of its descendants, K063073 (Candela Corp., 2006) has gone furthest, with 114 descendants of its own.

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	—

https://510kreport.com/device/K950831 · printed Nov 4, 2026

Cite this page

510(k) Report. “K950831: Alexlazr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950831

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026