510(k) · Cleared

Cleared

Candela Smoothbeam Laser System

K014128510(k) TraditionalCleared Oct 4, 2002291-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 Oct 4, 2002 as substantially equivalent to K002421 (Candela Corp., 2000) after a 291-day review. Its family tree reaches back 1 generation to 2000. 527 later devices descend from it.

Decided: Oct 4, 2002
Review: 291 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K002421 (2000). 527 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK002421 Candela Mid IR Diode Laser SystemCandela Corp. · 2000
This deviceK014128 Candela Smoothbeam Laser SystemCandela Corp. · 2002
Descendant · cites it directly · 524 of its ownK030453 Cooltouch ND: Yag Laser SystemNew Star Lasers, Inc. · 2003
Descendant · cites it directly · 518 of its ownK032459 Profile 1320 Laser SystemSciton, Inc · 2004
Descendant · 2 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
Descendant · 3 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
Descendant · 2 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006

Showing 5 of 527 descendants. See all descendants

Descendants cleared per year

2003high 63 (2024) · low 1 (2005)2026

Most influential descendants

Showing 5 of 527 · See all

K030453Cooltouch ND: Yag Laser SystemNew Star Lasers, Inc. · 2003 · cites it directly524descendants
K032459Profile 1320 Laser SystemSciton, Inc · 2004 · cites it directly518descendants
K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 2 generations on517descendants
K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 3 generations on266descendants
K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 2 generations on221descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002421	Candela Mid IR Diode Laser System	Candela Corp.	2000	—
0 (this device)	K014128	Candela Smoothbeam Laser System	Candela Corp.	2002	—
+1	K030453	Cooltouch ND: Yag Laser System	New Star Lasers, Inc.	2003	—
+1	K032459	Profile 1320 Laser System	Sciton, Inc	2004	—
+2	K042000	Modified MSQ Family of Lovely Light/Laser Systems	Msq (M2), Ltd.	2004	—
+3	K072564	Alma Lasers Harmony XL Multi-Application Platform	Alma Lasers, Ltd.	2008	—
+2	K060033	Profile Multi-Platform System	Sciton, Inc	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	3	0
2005	1	0
2006	3	0
2007	8	0
2008	17	0
2009	6	0
2010	14	0
2011	14	0
2012	11	0
2013	15	0
2014	20	0
2015	20	0
2016	32	0
2017	24	0
2018	25	0
2019	14	0
2020	33	0
2021	27	0
2022	43	0
2023	33	0
2024	63	0
2025	61	0
2026	38	0

FIG. 1 — Lineage of K014128, 2000–2026Source: 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? (1)

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
*	K002421	Candela Mid IR Diode Laser System Summary page 1 …nstrument for use in General and Plastic Surgery and in Dermatology) Predicate Device: Candela 1450 nm Diode laser (K002421) Description of the Smoothbeam Laser System: The Diode laser is a diode medical laser, controlled by an embedded processor, for…	Candela Corp.	2000	—

Also cleared against K002421: 1 other device →

What descends from it? (527)

See all 527

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

Number	Device	Applicant	Decided	Descendants
K030453	Cooltouch ND: Yag Laser System	New Star Lasers, Inc.	2003	524
K032459	Profile 1320 Laser System	Sciton, Inc	2004	518
K032514	AC Applicator, Aurora AC	Syneron Medical, Ltd.	2004	1
K032260	Aramis II Dermatological Laser	Quantel Medical	2003	1

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?

Its one ancestor has no recall.
Of its descendants, K030453 (New Star Lasers, Inc., 2003) has gone furthest, with 524 descendants of its own.
1 other device also cites its predicate K002421.

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 Smoothbeam Laser System is indicated for use for the treatment of back acne.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K014128 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014128: Candela Smoothbeam Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014128

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026