510(k) Report

510(k) · Cleared

Cleared

Candela Sclero Long Pulse Laser (Aka Vbeam)

K013748510(k) TraditionalCleared Feb 11, 200290-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 11, 2002 as substantially equivalent to K013043 (Candela Corp., 2001) and 5 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1991. 699 later devices descend from it.

Decided
Feb 11, 2002
Review
90 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K904627 (1991). 32 ancestors in all, the oldest K882160 (1988). 699 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2000: 1 other ancestor1996: 3 other ancestors1995: 5 other ancestors1999: 1 other ancestor1998: 2 other ancestors1997: 1 other ancestor1994: 8 other ancestors1988: 1 other ancestor1993: 2 other ancestors1991: 2 other ancestors2002: 2 descendants cleared2016: 38 descendants cleared2009: 12 descendants cleared2004: 7 descendants cleared2005: 6 descendants cleared2011: 23 descendants cleared2014: 29 descendants cleared2003: 5 descendants cleared2013: 24 descendants cleared2010: 18 descendants cleared2025: 82 descendants cleared2007: 12 descendants cleared2022: 52 descendants cleared2006: 5 descendants cleared2008: 24 descendants cleared2012: 20 descendants cleared2015: 27 descendants cleared2018: 32 descendants cleared2020: 41 descendants cleared2021: 31 descendants cleared2023: 41 descendants cleared2017: 31 descendants cleared2019: 21 descendants cleared2026: 46 descendants cleared2024: 70 descendants clearedK904627 · Centauri Yag Laser Syst, Ear, Nose , Throat · Pfizer Laser Systems · 1991K960032 · Coherent Versapulse Aesthetic Surgical Lasers · Coherent Medical Group · 1996K972347 · Modified Coherent Versapulse Aesthetic Surgical Laser · Lumenis, Inc. · 1997K993671 · Candela Sclero Long Pulse Dye Laser · Candela Corp. · 20001990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 5 other ancestors3 generations back: 3 other ancestors4 generations back: 15 other ancestors 1 generation forward: 4 descendants2 generations forward: 19 descendants3 generations forward: 44 descendants4 generations forward: 97 descendants5 generations forward: 120 descendants6 generations forward: 127 descendants7 generations forward: 95 descendants8 generations forward: 59 descendants9 generations forward: 52 descendants10 generations forward: 41 descendants11 generations forward: 31 descendants12 generations forward: 8 descendants13 generations forward: 2 descendants K993671 · Candela Sclero Long Pulse Dye Laser · Candela Corp. · 2000K972347 · Modified Coherent Versapulse Aesthetic Surgical Laser · Lumenis, Inc. · 1997K960032 · Coherent Versapulse Aesthetic Surgical Lasers · Coherent Medical Group · 1996K904627 · Centauri Yag Laser Syst, Ear, Nose , Throat · Pfizer Laser Systems · 19910+5+10
  1. Root · 4 generations backK904627 Centauri Yag Laser Syst, Ear, Nose , ThroatPfizer Laser Systems · 1991
  2. 3 generations backK960032 Coherent Versapulse Aesthetic Surgical LasersCoherent Medical Group · 1996
  3. 2 generations backK972347 Modified Coherent Versapulse Aesthetic Surgical LaserLumenis, Inc. · 1997
  4. 1 generation backK993671 Candela Sclero Long Pulse Dye LaserCandela Corp. · 2000
  5. This deviceK013748 Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp. · 2002
  6. Descendant · cites it directly · 665 of its ownK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
  7. Descendant · 2 generations on · 519 of its ownK033251 The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004
  8. Descendant · 3 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
  9. Descendant · cites it directly · 318 of its ownK021180 Candela Vbeam Pulsed Dye Laser SystemCandela Corp. · 2002
  10. Descendant · 2 generations on · 316 of its ownK033461 Candela Vbeam Pulse Dye Laser SystemCandela Corp. · 2004

Showing 5 of 699 descendants. See all descendants

Descendants cleared per year

2002: 22003: 52004: 72005: 62006: 52007: 122008: 242009: 122010: 182011: 232012: 202013: 242014: 292015: 272016: 382017: 312018: 322019: 212020: 412021: 312022: 522023: 412024: 702025: 822026: 46
2002high 82 (2025) · low 2 (2002)2026

Most influential descendants

Showing 5 of 699 · See all
  • 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 · cites it directly318descendants
  • K033461Candela Vbeam Pulse Dye Laser SystemCandela Corp. · 2004 · 2 generations on316descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K904627Centauri Yag Laser Syst, Ear, Nose , ThroatPfizer Laser Systems1991—
−3K960032Coherent Versapulse Aesthetic Surgical LasersCoherent Medical Group1996—
−2K972347Modified Coherent Versapulse Aesthetic Surgical LaserLumenis, Inc.1997—
−1K993671Candela Sclero Long Pulse Dye LaserCandela Corp.2000—
0 (this device)K013748Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp.2002—
+1K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II…Altus Medical, Inc.2002—
+2K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004—
+3K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004—
+1K021180Candela Vbeam Pulsed Dye Laser SystemCandela Corp.2002—
+2K033461Candela Vbeam Pulse Dye Laser SystemCandela Corp.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199120
199320
199480
199550
199630
199710
199820
199910
200010
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200350
200470
200560
200650
2007120
2008240
2009120
2010180
2011230
2012200
2013240
2014290
2015270
2016380
2017310
2018320
2019210
2020410
2021310
2022520
2023410
2024700
2025820
2026460
FIG. 1 — Lineage of K013748, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K013043Candela Clearbeam Pulsed Dye Laser
Summary page 1
…neral and Plastic Surgery and in Dermatology) Common Name: Dermatology Laser, Vbeam Pulse Dye Laser System Predicate Devices: Candela Clearbeam Pulse Dye Laser System (K013043) Candela SPTL-1e Pulse Dye Laser (K011092) Candela Long Pulsed Dye Laser (K993671) Candela SPTL Long Pulse/Tunable Pulse Dye L…
Candela Corp.2001—
*K011092Candela SPTL-1E Pulsed Dye Laser
Summary page 1
…y) Common Name: Dermatology Laser, Vbeam Pulse Dye Laser System Predicate Devices: Candela Clearbeam Pulse Dye Laser System (K013043) Candela SPTL-1e Pulse Dye Laser (K011092) Candela Long Pulsed Dye Laser (K993671) Candela SPTL Long Pulse/Tunable Pulse Dye Laser (K943292, K954934) SLS Biophile Ltd.…
Candela Corp.2001—
*K993671Candela Sclero Long Pulse Dye Laser
Summary page 1
…Pulse Dye Laser System Predicate Devices: Candela Clearbeam Pulse Dye Laser System (K013043) Candela SPTL-1e Pulse Dye Laser (K011092) Candela Long Pulsed Dye Laser (K993671) Candela SPTL Long Pulse/Tunable Pulse Dye Laser (K943292, K954934) SLS Biophile Ltd. NLite Pulse Dye Laser (K000811) Descript…
Candela Corp.2000—
*K943292Candela SPTL Variable Pulse/Tunable Pulsed Dye Lasers
Summary page 1
…am Pulse Dye Laser System (K013043) Candela SPTL-1e Pulse Dye Laser (K011092) Candela Long Pulsed Dye Laser (K993671) Candela SPTL Long Pulse/Tunable Pulse Dye Laser (K943292, K954934) SLS Biophile Ltd. NLite Pulse Dye Laser (K000811) Description: The Vbeam Pulse Dye laser is a 595 nm, flash lamp exci…
Candela Laser Corp.1995—
*K954934Candela SPTL Long Pulse/Tunable Pulsed Dye Lase
Summary page 1
…ye Laser System (K013043) Candela SPTL-1e Pulse Dye Laser (K011092) Candela Long Pulsed Dye Laser (K993671) Candela SPTL Long Pulse/Tunable Pulse Dye Laser (K943292, K954934) SLS Biophile Ltd. NLite Pulse Dye Laser (K000811) Description: The Vbeam Pulse Dye laser is a 595 nm, flash lamp excited pulsed…
Candela Laser Corp.1996—
*K000811Nlite System, SLS Model Number A00-1025
Summary page 1
…e Laser (K011092) Candela Long Pulsed Dye Laser (K993671) Candela SPTL Long Pulse/Tunable Pulse Dye Laser (K943292, K954934) SLS Biophile Ltd. NLite Pulse Dye Laser (K000811) Description: The Vbeam Pulse Dye laser is a 595 nm, flash lamp excited pulsed dye medical laser, controlled by an embedded micro…
Sls Biophile, Ltd.2000—

Also cleared against K013043: 3 other devices →

What descends from it? (699)

See all 699

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

NumberDeviceApplicantDecidedDescendants
K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665
K021180Candela Vbeam Pulsed Dye Laser SystemCandela Corp.2002318
K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198
K151337StrialiteCentre Light Solutions, LLC20160

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 11 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
  • None of the 32 ancestors has a recall.
  • Of its descendants, K022226 (Altus Medical, Inc., 2002) has gone furthest, with 665 descendants of its own.
  • 3 other devices also cite its predicate K013043.

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

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
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

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

What is it indicated for?

The Candela Vbeam Pulse Dye Laser System is indicated for the following uses in:

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, and psoriasis.

Treatment of periocular wrinkles.

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

gynecology.

Podiatry: Treatment of benign cutaneous lesions, 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.

Also cleared against K013043

3 other devices cite the same predicate.

  • K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future ModelsAltus Medical, Inc. · 2002
  • K020958Candela Cbeam Pulsed Dye Laser SystemCandela Corp. · 2002
  • K020729Nlite System,Model A00-1051Icn Photonics, Ltd. · 2002

More from Candela Corp.

48 FDA decisions under this applicant name. See the company

  • K183452Vbeam Prima Laser SystemCandela Corp. · 2019
  • K140732Candela Gentlelase Family of Laser SystemsCandela Corp. · 2014
  • K140122Candela Gentlemax Family of Laser SystemCandela Corp. · 2014
  • K133283Candela Gentlemax Family of Laser SystemsCandela Corp. · 2013
  • K112715Candela Gentlemax Family of LasersCandela Corp. · 2011

Recent decisions in GEX

The GEX category page

  • K262701PicoPeak Picosecond Nd:Yag Laser System (Bella-9)Beijing Sea Heart International Science and Technologyco.Ltd · 2026
  • K262628Picosecond Laser treatment system (Z180)Sanhe PERFECTLASER Technology Co., Ltd. · 2026
  • K261572Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)Keyue (Hangzhou) Medical Information Technology Co., Ltd. · 2026
  • K262346CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight…Wuhan Phomed Technology Co., Ltd. · 2026
  • K261692Diode Laser Hair Removal Machine (QDTM-03)Beijing Nubway S&T Co., Ltd. · 2026

https://510kreport.com/device/K013748 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013748: Candela Sclero Long Pulse Laser (Aka Vbeam).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013748

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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