510(k) · Cleared

Recalled · 2003

Candela Smoothbeam Laser System

K013825510(k) TraditionalCleared Feb 15, 200288-day reviewClass II21 CFR 878.4810Recalls 1

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 Feb 15, 2002 as substantially equivalent to K003715 (Cooltouch Corp., 2001) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 2000. 740 later devices descend from it. It has been recalled once.

Decided: Feb 15, 2002
Review: 88 days
Class: Class II
Product code: GEX
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K002421 (2000). 2 ancestors in all. 740 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK002421 Candela Mid IR Diode Laser SystemCandela Corp. · 2000
This deviceK013825 Candela Smoothbeam Laser SystemCandela Corp. · 2002
Descendant · cites it directly · 665 of its ownK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
Descendant · cites it directly · 642 of its ownK022884 Candela Smoothbeam Laser SystemCandela Corp. · 2003 · Recalled
Descendant · 2 generations on · 603 of its ownK030834 Candela Smoothbeam Laser SystemCandela Corp. · 2003 · Recalled
Descendant · 3 generations on · 569 of its ownK040131 Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser SystemNew Star Lasers, Inc. · 2004
Descendant · 2 generations on · 524 of its ownK030453 Cooltouch ND: Yag Laser SystemNew Star Lasers, Inc. · 2003

Showing 5 of 740 descendants. See all descendants

Descendants cleared per year

2002high 86 (2025) · low 1 (2002)2026

Most influential descendants

Showing 5 of 740 · See all

K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc. · 2002 · cites it directly665descendants
K022884Candela Smoothbeam Laser SystemCandela Corp. · 2003 · cites it directly642descendants
K030834Candela Smoothbeam Laser SystemCandela Corp. · 2003 · 2 generations on603descendants
K040131Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser SystemNew Star Lasers, Inc. · 2004 · 3 generations on569descendants
K030453Cooltouch ND: Yag Laser SystemNew Star Lasers, Inc. · 2003 · 2 generations on524descendants

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)	K013825	Candela Smoothbeam Laser System	Candela Corp.	2002	—
+1	K022226	Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II…	Altus Medical, Inc.	2002	—
+1	K022884	Candela Smoothbeam Laser System	Candela Corp.	2003	1
+2	K030834	Candela Smoothbeam Laser System	Candela Corp.	2003	1
+3	K040131	Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser System	New Star Lasers, Inc.	2004	—
+2	K030453	Cooltouch ND: Yag Laser System	New Star Lasers, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	10	0
2004	9	0
2005	5	0
2006	6	0
2007	16	0
2008	26	0
2009	15	0
2010	19	0
2011	24	0
2012	21	0
2013	27	0
2014	30	0
2015	27	0
2016	37	0
2017	33	0
2018	32	0
2019	23	0
2020	42	0
2021	32	0
2022	56	0
2023	44	0
2024	71	0
2025	86	0
2026	48	0

FIG. 1 — Lineage of K013825, 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

Get a 510(k) Report

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
*	K003715	Cooltouch ND:Yag Laser System, Cooltouch-II ND:Yag Laser System, Model Cooltouch… Summary page 1 …ication: Class I1 (21 CFR § 878.4810 Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology) Predicate Devices: Laser Aesthetics CoolTouch (K003715) and Candela 1450 nm Diode laser (K002421) Description of the Smoothbeam Laser System: The Diode laser is a Continuous Wave, di…	Cooltouch Corp.	2001	—
*	K002421	Candela Mid IR Diode Laser System Summary page 1 …Surgical Instrument for use in General and Plastic Surgery and in Dermatology) Predicate Devices: Laser Aesthetics CoolTouch (K003715) and Candela 1450 nm Diode laser (K002421) Description of the Smoothbeam Laser System: The Diode laser is a Continuous Wave, diode medical laser, controlled by an embedd…	Candela Corp.	2000	—

Also cleared against K003715: 5 other devices →

What descends from it? (740)

See all 740

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

Number	Device	Applicant	Decided	Descendants
K022226	Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…	Altus Medical, Inc.	2002	665
K022884	Candela Smoothbeam Laser System	Candela Corp.	2003	642
K032459	Profile 1320 Laser System	Sciton, Inc	2004	518
K023734	Aramis II Dermatological Laser	Quantel Medical	2003	317
K041242	Candela Smoothbeam Laser System	Candela Corp.	2004	229

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 25, 2003	Not classified	Z-0291-04	Other	Laser may pulse and not dispense cryogen resulting in patient injury

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, K022226 (Altus Medical, Inc., 2002) has gone furthest, with 665 descendants of its own.
5 other devices also cite its predicate K003715.

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 in dermatology for incision, excision, ablation, vaporization with hemostasis of soft tissue and the treatment of periorbital wrinkles.

The intended use of the Candela Dynamic Cooling Device is:

Cooling of the skin prior to laser treatment

Reduction of pain during laser treatment

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K013825 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013825: Candela Smoothbeam Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013825

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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