510(k) · Cleared

Cleared

Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1B

K043251510(k) TraditionalCleared Feb 9, 200578-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 Feb 9, 2005 as substantially equivalent to K001093 (Candela Corp., 2000) and 7 other predicates after a 78-day review. Its family tree reaches back 7 generations to 1991. 136 later devices descend from it.

Decided: Feb 9, 2005
Review: 78 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 8

Its longest line of descent runs back 7 generations to K904627 (1991). 57 ancestors in all, the oldest K882160 (1988). 136 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 7 generations backK904627 Centauri Yag Laser Syst, Ear, Nose , ThroatPfizer Laser Systems · 1991
6 generations backK960032 Coherent Versapulse Aesthetic Surgical LasersCoherent Medical Group · 1996
5 generations backK972347 Modified Coherent Versapulse Aesthetic Surgical LaserLumenis, Inc. · 1997
4 generations backK993671 Candela Sclero Long Pulse Dye LaserCandela Corp. · 2000
3 generations backK013748 Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp. · 2002
2 generations backK021180 Candela Vbeam Pulsed Dye Laser SystemCandela Corp. · 2002
1 generation backK033461 Candela Vbeam Pulse Dye Laser SystemCandela Corp. · 2004
This deviceK043251 Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam…Candela Corp. · 2005
Descendant · cites it directly · 133 of its ownK050673 Candela Family of Pulse Dye Laser SystemsCandela Corp. · 2005 · Recalled
Descendant · cites it directly · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007
Descendant · 2 generations on · 112 of its ownK081352 Profile Multi-Platform SystemSciton, Inc · 2008
Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Descendant · 3 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014

Showing 5 of 136 descendants. See all descendants

Descendants cleared per year

2005high 18 (2022) · low 0 (2012)2026

Most influential descendants

Showing 5 of 136 · See all

K050673Candela Family of Pulse Dye Laser SystemsCandela Corp. · 2005 · cites it directly133descendants
K070388Profile Multi-Platform SystemSciton, Inc · 2007 · cites it directly129descendants
K081352Profile Multi-Platform SystemSciton, Inc · 2008 · 2 generations on112descendants
K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 2 generations on111descendants
K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 3 generations on70descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K904627	Centauri Yag Laser Syst, Ear, Nose , Throat	Pfizer Laser Systems	1991	—
−6	K960032	Coherent Versapulse Aesthetic Surgical Lasers	Coherent Medical Group	1996	—
−5	K972347	Modified Coherent Versapulse Aesthetic Surgical Laser	Lumenis, Inc.	1997	—
−4	K993671	Candela Sclero Long Pulse Dye Laser	Candela Corp.	2000	—
−3	K013748	Candela Sclero Long Pulse Laser (Aka Vbeam)	Candela Corp.	2002	—
−2	K021180	Candela Vbeam Pulsed Dye Laser System	Candela Corp.	2002	—
−1	K033461	Candela Vbeam Pulse Dye Laser System	Candela Corp.	2004	—
0 (this device)	K043251	Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1B	Candela Corp.	2005	—
+1	K050673	Candela Family of Pulse Dye Laser Systems	Candela Corp.	2005	2
+1	K070388	Profile Multi-Platform System	Sciton, Inc	2007	—
+2	K081352	Profile Multi-Platform System	Sciton, Inc	2008	—
+2	K101916	Joule Multi-Platform System	Sciton, Inc	2011	—
+3	K132806	Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece	Fotona D.D.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1991	2	0
1993	2	0
1994	8	0
1995	6	0
1996	5	0
1997	5	0
1998	5	0
1999	4	0
2000	3	0
2001	2	0
2002	2	0
2003	4	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	1	0
2007	1	0
2008	6	0
2009	2	0
2010	3	0
2011	1	0
2014	3	0
2015	6	0
2016	1	0
2017	4	0
2018	10	0
2019	8	0
2020	11	0
2021	9	0
2022	18	0
2023	10	0
2024	14	0
2025	15	0
2026	11	0

FIG. 1 — Lineage of K043251, 1991–2026Source: 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? (8)

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
*	K001093	Candela SPTL-1B Pulsed Dye Laser Summary page 1 …Benign Epidermal Pigmented Lesions There have been no modifications in design of the Lasers in the Pulsed Dye Family of Laser Systems which were previously cleared under K001093, K021180, K033331 and K033461. Submitted by: Candela Corporation 530 B…	Candela Corp.	2000	—
*	K021180	Candela Vbeam Pulsed Dye Laser System Summary page 1 …idermal Pigmented Lesions There have been no modifications in design of the Lasers in the Pulsed Dye Family of Laser Systems which were previously cleared under K001093, K021180, K033331 and K033461. Submitted by: Candela Corporation 530 Boston Pos…	Candela Corp.	2002	—
*	K033331	Candela Cbeam Pulse Dye Laser System Summary page 1 …igmented Lesions There have been no modifications in design of the Lasers in the Pulsed Dye Family of Laser Systems which were previously cleared under K001093, K021180, K033331 and K033461. Submitted by: Candela Corporation 530 Boston Post Road…	Candela Corp.	2004	—
*	K033461	Candela Vbeam Pulse Dye Laser System Summary page 1 …ions There have been no modifications in design of the Lasers in the Pulsed Dye Family of Laser Systems which were previously cleared under K001093, K021180, K033331 and K033461. Submitted by: Candela Corporation 530 Boston Post Road…	Candela Corp.	2004	—
*	K031488	Cynosure Apogee-TKS II Dermatological Laser Summary page 2 …Candela Famil of Pulsed Dye Laser Sstems 510k Summary Clearbe am) K001093 K02118 K03346 K031488 K984424 K024371 0 1 K024206 K03333…	Cynosure, Inc.	2003	—
*	K984424	Aura Dye Laser System (Adls) Summary page 2 …Candela Famil of Pulsed Dye Laser Sstems 510k Summary Clearbe am) K001093 K02118 K03346 K031488 K984424 K024371 0 1 K024206 K03333 I…	Laserscope	1999	—
*	K024206	Aura Isurgical Laser System & Accessories Summary page 2 …Clearbe am) K001093 K02118 K03346 K031488 K984424 K024371 0 1 K024206 K03333 I Description: The Candela Family of Pulse Dye Laser Systems are flash-lamp ex…	Laserscope	2003	—
*	K024371	Candela Gentle Lase Family of Laser System Summary page 2 …la Famil of Pulsed Dye Laser Sstems 510k Summary Clearbe am) K001093 K02118 K03346 K031488 K984424 K024371 0 1 K024206 K03333 I Description:…	Candela Corp.	2003	—

What descends from it? (136)

See all 136

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

Number	Device	Applicant	Decided	Descendants
K050673	Candela Family of Pulse Dye Laser Systems	Candela Corp.	2005	133
K070388	Profile Multi-Platform System	Sciton, Inc	2007	129
K132976	Advatx	Advalight Aps	2014	1
K051359	Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece Accessory	Candela Corp.	2005	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?

The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
1 of the 57 ancestors has a recall of any class.
Of its descendants, K050673 (Candela Corp., 2005) has gone furthest, with 133 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	—

What is it indicated for?

The Candela Family of Pulse Dye Laser Systems 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 lesions, such as warts, scars, striae and…

Read the full statement (103 words)

The Candela Family of Pulse Dye Laser Systems 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 lesions, such as warts, scars, striae and psoriasis. and the treatment of wrinkles.

Treatment of Inflammatory Acne Vulgaris

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

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

New Indication: Treatment of Benign Epidermal Pigmented Lesions

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043251 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043251: Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043251

Report an extraction error

Are you the manufacturer?

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