510(k) Report

510(k) · Cleared

Cleared

Candela Smoothbeam Laser System

K041242510(k) TraditionalCleared Nov 22, 2004195-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 Nov 22, 2004 as substantially equivalent to K013825 (Candela Corp., 2002) and 1 other predicate after a 195-day review. Its family tree reaches back 4 generations to 2000. 229 later devices descend from it.

Decided
Nov 22, 2004
Review
195 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K002421 (2000). 5 ancestors in all. 229 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2007: 4 descendants cleared2018: 16 descendants cleared2026: 13 descendants cleared2022: 24 descendants cleared2006: 1 descendant cleared2008: 11 descendants cleared2010: 6 descendants cleared2009: 5 descendants cleared2011: 6 descendants cleared2025: 28 descendants cleared2023: 16 descendants cleared2021: 11 descendants cleared2014: 6 descendants cleared2020: 16 descendants cleared2013: 3 descendants cleared2012: 2 descendants cleared2024: 25 descendants cleared2016: 9 descendants cleared2015: 10 descendants cleared2017: 9 descendants cleared2019: 8 descendants clearedK002421 · Candela Mid IR Diode Laser System · Candela Corp. · 2000K013825 · Candela Smoothbeam Laser System · Candela Corp. · 2002 · recalledK022884 · Candela Smoothbeam Laser System · Candela Corp. · 2003 · recalledK030834 · Candela Smoothbeam Laser System · Candela Corp. · 2003 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 14 descendants3 generations forward: 15 descendants4 generations forward: 34 descendants5 generations forward: 46 descendants6 generations forward: 42 descendants7 generations forward: 30 descendants8 generations forward: 18 descendants9 generations forward: 11 descendants10 generations forward: 9 descendants11 generations forward: 4 descendants12 generations forward: 1 descendant K030834 · Candela Smoothbeam Laser System · Candela Corp. · 2003 · recalledK022884 · Candela Smoothbeam Laser System · Candela Corp. · 2003 · recalledK013825 · Candela Smoothbeam Laser System · Candela Corp. · 2002 · recalledK002421 · Candela Mid IR Diode Laser System · Candela Corp. · 20000+5+10
  1. Root · 4 generations backK002421 Candela Mid IR Diode Laser SystemCandela Corp. · 2000
  2. 3 generations backK013825 Candela Smoothbeam Laser SystemCandela Corp. · 2002 · Recalled
  3. 2 generations backK022884 Candela Smoothbeam Laser SystemCandela Corp. · 2003 · Recalled
  4. 1 generation backK030834 Candela Smoothbeam Laser SystemCandela Corp. · 2003 · Recalled
  5. This deviceK041242 Candela Smoothbeam Laser SystemCandela Corp. · 2004
  6. Descendant · cites it directly · 205 of its ownK053047 Fraxel SR Laser SystemReliant Technologies, Inc. · 2006
  7. Descendant · 2 generations on · 195 of its ownK063038 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007
  8. Descendant · 2 generations on · 194 of its ownK071051 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007
  9. Descendant · 3 generations on · 187 of its ownK080915 Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc. · 2008
  10. Descendant · 4 generations on · 158 of its ownK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009

Showing 5 of 229 descendants. See all descendants

Descendants cleared per year

2006: 12007: 42008: 112009: 52010: 62011: 62012: 22013: 32014: 62015: 102016: 92017: 92018: 162019: 82020: 162021: 112022: 242023: 162024: 252025: 282026: 13
2006high 28 (2025) · low 1 (2006)2026

Most influential descendants

Showing 5 of 229 · See all
  • K053047Fraxel SR Laser SystemReliant Technologies, Inc. · 2006 · cites it directly205descendants
  • K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007 · 2 generations on195descendants
  • K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007 · 2 generations on194descendants
  • K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc. · 2008 · 3 generations on187descendants
  • K083900Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009 · 4 generations on158descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K002421Candela Mid IR Diode Laser SystemCandela Corp.2000—
−3K013825Candela Smoothbeam Laser SystemCandela Corp.20021
−2K022884Candela Smoothbeam Laser SystemCandela Corp.20031
−1K030834Candela Smoothbeam Laser SystemCandela Corp.20031
0 (this device)K041242Candela Smoothbeam Laser SystemCandela Corp.2004—
+1K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006—
+2K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007—
+2K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007—
+3K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008—
+4K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200740
2008110
200950
201060
201160
201220
201330
201460
2015100
201690
201790
2018160
201980
2020160
2021110
2022240
2023160
2024250
2025280
2026130
FIG. 1 — Lineage of K041242, 2000–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K013825Candela Smoothbeam Laser System
Summary page 1
…gy) Common Name: Dermatology Laser, Smoothbeam Laser System Predicate Devices: Candela Smoothbeam 1450 nm Diode Laser System (K013825 ,K030834) Description: The Diode laser is a Continuous Wave, diode medical laser, controlled by an embedded processor, to be us…
Candela Corp.20021
*K030834Candela Smoothbeam Laser System
Summary page 1
…on Name: Dermatology Laser, Smoothbeam Laser System Predicate Devices: Candela Smoothbeam 1450 nm Diode Laser System (K013825 ,K030834) Description: The Diode laser is a Continuous Wave, diode medical laser, controlled by an embedded processor, to be used…
Candela Corp.20031

Also cleared against K013825: 4 other devices →

What descends from it? (229)

See all 229

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

NumberDeviceApplicantDecidedDescendants
K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205
K070388Profile Multi-Platform SystemSciton, Inc2007129
K213461AviClear Laser SystemCutera, Inc.20222
K173676A-FITHironic Co., Ltd.20181
K254271CAPRIORO Co., Ltd.20260

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 4 years and passes through 1 company; a new generation was cleared every 12 months on median.
  • 3 of the 5 ancestors have a recall of any class.
  • Of its descendants, K053047 (Reliant Technologies, Inc., 2006) has gone furthest, with 205 descendants of its own.
  • 4 other devices also cite its predicate K013825.

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 Smoothbeam Laser is indicated for the following uses:

For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue

Treatment of back acne

Treatment of atrophic acne scars

Treatment of facial wrinkles

Treatment of mild to moderate acne vulgaris

New indication: Treatment of Sebaceous Hyperplasia

Indications for use as stated in the FDA summary.

Also cleared against K013825

4 other devices cite the same predicate.

  • K032459Profile 1320 Laser SystemSciton, Inc · 2004
  • K023734Aramis II Dermatological LaserQuantel Medical · 2003
  • K022884Candela Smoothbeam Laser SystemCandela Corp. · 20031 recall
  • K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future ModelsAltus Medical, Inc. · 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/K041242 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041242: Candela Smoothbeam 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/K041242

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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