510(k) · Cleared

Cleared

Vbeam Prima Laser System

K180593510(k) TraditionalCleared Jun 5, 201891-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

Syneron-Candela · GEX Powered Laser Surgical Instrument

Cleared on Jun 5, 2018 as substantially equivalent to K050673 (Candela Corp., 2005) and 1 other predicate after a 91-day review. Its family tree reaches back 9 generations to 1991. 2 later devices descend from it.

Decided: Jun 5, 2018
Review: 91 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 9 generations to K904627 (1991). 62 ancestors in all, the oldest K882160 (1988). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 9 generations backK904627 Centauri Yag Laser Syst, Ear, Nose , ThroatPfizer Laser Systems · 1991
5 generations between
3 generations backK033461 Candela Vbeam Pulse Dye Laser SystemCandela Corp. · 2004
2 generations backK043251 Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam…Candela Corp. · 2005
1 generation backK050673 Candela Family of Pulse Dye Laser SystemsCandela Corp. · 2005 · Recalled
This deviceK180593 Vbeam Prima Laser SystemSyneron-Candela · 2018
Descendant · cites it directly · 1 of its ownK183452 Vbeam Prima Laser SystemCandela Corp. · 2019
Descendant · 2 generations on · 0 of its ownK230990 Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam…Candela Corporation · 2023

Show all 9 generations

Root · 9 generations backK904627 Centauri Yag Laser Syst, Ear, Nose , ThroatPfizer Laser Systems · 1991
8 generations backK960032 Coherent Versapulse Aesthetic Surgical LasersCoherent Medical Group · 1996
7 generations backK972347 Modified Coherent Versapulse Aesthetic Surgical LaserLumenis, Inc. · 1997
6 generations backK993671 Candela Sclero Long Pulse Dye LaserCandela Corp. · 2000
5 generations backK013748 Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp. · 2002
4 generations backK021180 Candela Vbeam Pulsed Dye Laser SystemCandela Corp. · 2002
3 generations backK033461 Candela Vbeam Pulse Dye Laser SystemCandela Corp. · 2004
2 generations backK043251 Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam…Candela Corp. · 2005
1 generation backK050673 Candela Family of Pulse Dye Laser SystemsCandela Corp. · 2005 · Recalled
This deviceK180593 Vbeam Prima Laser SystemSyneron-Candela · 2018

Most influential descendants

Showing 2 of 2 · See all

K183452Vbeam Prima Laser SystemCandela Corp. · 2019 · cites it directly1descendant
K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation · 2023 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−9	K904627	Centauri Yag Laser Syst, Ear, Nose , Throat	Pfizer Laser Systems	1991	—
−8	K960032	Coherent Versapulse Aesthetic Surgical Lasers	Coherent Medical Group	1996	—
−7	K972347	Modified Coherent Versapulse Aesthetic Surgical Laser	Lumenis, Inc.	1997	—
−6	K993671	Candela Sclero Long Pulse Dye Laser	Candela Corp.	2000	—
−5	K013748	Candela Sclero Long Pulse Laser (Aka Vbeam)	Candela Corp.	2002	—
−4	K021180	Candela Vbeam Pulsed Dye Laser System	Candela Corp.	2002	—
−3	K033461	Candela Vbeam Pulse Dye Laser System	Candela Corp.	2004	—
−2	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
0 (this device)	K180593	Vbeam Prima Laser System	Syneron-Candela	2018	—
+1	K183452	Vbeam Prima Laser System	Candela Corp.	2019	—
+2	K230990	Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)	Candela Corporation	2023	—

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	5	0
2004	2	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0
2023	1	0

FIG. 1 — Lineage of K180593, 1991–2023Source: 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? (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
*	K050673	Candela Family of Pulse Dye Laser Systems Summary page 4 …EX Device Classification: Class 2 Laser Classification: Class IV 5. PREDICATE DEVICE Candela Family of Pulsed Dye Laser Systems (K050673), primary predicate Cynosure Cynergy Multiplex Laser (K050779), additional predicate…	Candela Corp.	2005	2
*	K050779	Cynergy Multiplex Laser Summary page 4 …cation: Class IV 5. PREDICATE DEVICE Candela Family of Pulsed Dye Laser Systems (K050673), primary predicate Cynosure Cynergy Multiplex Laser (K050779), additional predicate Page 903 of 906 === P…	Cynosure, Inc.	2005	—

Also cleared against K050673: 2 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K183452	Vbeam Prima Laser System	Candela Corp.	2019	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 27 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
2 of the 62 ancestors have a recall of any class.
Of its descendants, K183452 (Candela Corp., 2019) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K050673.

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. 2018, this device’s year, is highlighted.

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?

1,064nm: The Vbeam Prima Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lakes, leg veins, spider veins, and poikiloderma of civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), cafe au lait manules, seborrheic keratoses, nevi, chloasma…

Read the full statement (179 words)

1,064nm:

The Vbeam Prima Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lakes, leg veins, spider veins, and poikiloderma of civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), cafe au lait manules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, and keratoses. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

595 nm:

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

Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, 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, psoriasis and the treatment of wrinkles. Treatment of benign epidermal pigmented lesions. Treatment of inflammatory acne vulgaris.

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

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K180593 · printed Nov 6, 2026

Cite this page

510(k) Report. “K180593: Vbeam Prima 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/K180593

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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