510(k) · Cleared

Cleared

Candela Clearbeam Pulsed Dye Laser

K013043510(k) TraditionalCleared Oct 11, 200131-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 11, 2001 as substantially equivalent to K011092 (Candela Corp., 2001) and 1 other predicate after a 31-day review. Its family tree reaches back 1 generation to 2000. 703 later devices descend from it.

Decided: Oct 11, 2001
Review: 31 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K000811 (2000). 2 ancestors in all. 703 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK000811 Nlite System, SLS Model Number A00-1025Sls Biophile, Ltd. · 2000
This deviceK013043 Candela Clearbeam Pulsed Dye LaserCandela Corp. · 2001
Descendant · cites it directly · 699 of its ownK013748 Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp. · 2002
Descendant · cites it directly · 665 of its ownK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
Descendant · 2 generations on · 519 of its ownK033251 The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004
Descendant · 3 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
Descendant · 2 generations on · 318 of its ownK021180 Candela Vbeam Pulsed Dye Laser SystemCandela Corp. · 2002

Showing 5 of 703 descendants. See all descendants

Descendants cleared per year

2002high 82 (2025) · low 5 (2002)2026

Most influential descendants

Showing 5 of 703 · See all

K013748Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp. · 2002 · cites it directly699descendants
K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc. · 2002 · cites it directly665descendants
K033251The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004 · 2 generations on519descendants
K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 3 generations on517descendants
K021180Candela Vbeam Pulsed Dye Laser SystemCandela Corp. · 2002 · 2 generations on318descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000811	Nlite System, SLS Model Number A00-1025	Sls Biophile, Ltd.	2000	—
0 (this device)	K013043	Candela Clearbeam Pulsed Dye Laser	Candela Corp.	2001	—
+1	K013748	Candela Sclero Long Pulse Laser (Aka Vbeam)	Candela Corp.	2002	—
+1	K022226	Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II…	Altus Medical, Inc.	2002	—
+2	K033251	The Friendlylight ND: Yag Lasers	Innotech USA, Inc.	2004	—
+3	K042000	Modified MSQ Family of Lovely Light/Laser Systems	Msq (M2), Ltd.	2004	—
+2	K021180	Candela Vbeam Pulsed Dye Laser System	Candela Corp.	2002	—

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	5	0
2003	5	0
2004	8	0
2005	6	0
2006	5	0
2007	12	0
2008	24	0
2009	12	0
2010	18	0
2011	23	0
2012	20	0
2013	24	0
2014	29	0
2015	27	0
2016	38	0
2017	31	0
2018	32	0
2019	21	0
2020	41	0
2021	31	0
2022	52	0
2023	41	0
2024	70	0
2025	82	0
2026	46	0

FIG. 1 — Lineage of K013043, 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
*	K011092	Candela SPTL-1E Pulsed Dye Laser	Candela Corp.	2001	—
*	K000811	Nlite System, SLS Model Number A00-1025	Sls Biophile, Ltd.	2000	—

Also cleared against K011092: 2 other devices →

What descends from it? (703)

See all 703

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

Number	Device	Applicant	Decided	Descendants
K013748	Candela Sclero Long Pulse Laser (Aka Vbeam)	Candela Corp.	2002	699
K022226	Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…	Altus Medical, Inc.	2002	665
K020958	Candela Cbeam Pulsed Dye Laser System	Candela Corp.	2002	231
K020729	Nlite System,Model A00-1051	Icn Photonics, Ltd.	2002	3

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, K013748 (Candela Corp., 2002) has gone furthest, with 699 descendants of its own.
2 other devices also cite its predicate K011092.

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 Clearbeam Pulse Dye Laser is indicated for the following uses in:

General Surgery: Photocoagulation of benign cutaneous vascular lesion and benign cutaneous lesions.

Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesion, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, poikiloderma of Civatte and benign cutaneous lesion, such as warts, scars, striea and psoriasis. Treatment of periocular wrinkles.

Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology

Podiatry: Treatment of benign cutaneous lesion, such as warts.

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/K013043 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013043: Candela Clearbeam Pulsed Dye Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013043

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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