510(k) Report

510(k) · Cleared

Cleared

Coherent Versapulse Aesthetic Surgical Lasers

K960032510(k) TraditionalCleared Apr 1, 199690-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

Coherent Medical Group · GEX Powered Laser Surgical Instrument

Cleared on Apr 1, 1996 as substantially equivalent to K941841 (Laserscope, 1994) and 15 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1991. 1,152 later devices descend from it.

Decided
Apr 1, 1996
Review
90 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
16

Its longest line of descent runs back 1 generation to K904627 (1991). 16 ancestors in all. 1,152 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 4 other ancestors1994: 7 other ancestors1993: 2 other ancestors1991: 2 other ancestors1998: 2 descendants cleared2002: 5 descendants cleared2005: 22 descendants cleared1997: 2 descendants cleared2003: 12 descendants cleared2006: 26 descendants cleared2011: 31 descendants cleared2004: 14 descendants cleared2007: 27 descendants cleared2008: 44 descendants cleared2013: 39 descendants cleared2014: 42 descendants cleared2009: 30 descendants cleared2000: 2 descendants cleared2016: 55 descendants cleared2012: 28 descendants cleared2020: 55 descendants cleared2010: 30 descendants cleared2015: 44 descendants cleared2025: 128 descendants cleared2017: 56 descendants cleared2022: 82 descendants cleared2023: 67 descendants cleared2018: 47 descendants cleared2019: 41 descendants cleared2024: 94 descendants cleared2021: 50 descendants cleared2026: 77 descendants clearedK904627 · Centauri Yag Laser Syst, Ear, Nose , Throat · Pfizer Laser Systems · 19911990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 15 other ancestors 1 generation forward: 6 descendants2 generations forward: 31 descendants3 generations forward: 99 descendants4 generations forward: 150 descendants5 generations forward: 194 descendants6 generations forward: 231 descendants7 generations forward: 160 descendants8 generations forward: 116 descendants9 generations forward: 80 descendants10 generations forward: 39 descendants11 generations forward: 23 descendants12 generations forward: 14 descendants13 generations forward: 6 descendants14 generations forward: 3 descendants K904627 · Centauri Yag Laser Syst, Ear, Nose , Throat · Pfizer Laser Systems · 19910+5+10
  1. Root · 1 generation backK904627 Centauri Yag Laser Syst, Ear, Nose , ThroatPfizer Laser Systems · 1991
  2. This deviceK960032 Coherent Versapulse Aesthetic Surgical LasersCoherent Medical Group · 1996
  3. Descendant · cites it directly · 1,142 of its ownK972347 Modified Coherent Versapulse Aesthetic Surgical LaserLumenis, Inc. · 1997
  4. Descendant · 2 generations on · 1,064 of its ownK001589 Candela Dynamic Cooling DeviceCandela Corp. · 2000
  5. Descendant · cites it directly · 1,046 of its ownK020839 Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002
  6. Descendant · 2 generations on · 856 of its ownK030527 Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003
  7. Descendant · 2 generations on · 756 of its ownK030342 Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd. · 2003 · Recalled

Showing 5 of 1,152 descendants. See all descendants

Descendants cleared per year

1997: 21998: 22000: 22002: 52003: 122004: 142005: 222006: 262007: 272008: 442009: 302010: 302011: 312012: 282013: 392014: 422015: 442016: 552017: 562018: 472019: 412020: 552021: 502022: 822023: 672024: 942025: 1282026: 77
1997high 128 (2025) · low 0 (1999)2026

Most influential descendants

Showing 5 of 1,152 · See all
  • K972347Modified Coherent Versapulse Aesthetic Surgical LaserLumenis, Inc. · 1997 · cites it directly1,142descendants
  • K001589Candela Dynamic Cooling DeviceCandela Corp. · 2000 · 2 generations on1,064descendants
  • K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002 · cites it directly1,046descendants
  • K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003 · 2 generations on856descendants
  • K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd. · 2003 · 2 generations on756descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K904627Centauri Yag Laser Syst, Ear, Nose , ThroatPfizer Laser Systems1991—
0 (this device)K960032Coherent Versapulse Aesthetic Surgical LasersCoherent Medical Group1996—
+1K972347Modified Coherent Versapulse Aesthetic Surgical LaserLumenis, Inc.1997—
+2K001589Candela Dynamic Cooling DeviceCandela Corp.2000—
+1K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc.2002—
+2K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis2003—
+2K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd.20031

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199120
199320
199470
199540

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199820
200020
200250
2003120
2004140
2005220
2006260
2007270
2008440
2009300
2010300
2011310
2012280
2013390
2014420
2015440
2016550
2017560
2018470
2019410
2020550
2021500
2022820
2023670
2024940
20251280
2026770
FIG. 1 — Lineage of K960032, 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? (16)

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
*K941841Smartscan
Summary page 1
…Primary Classification Name: Laser Powered Surgical Instrument (and Accessories). Predicate Devices *» Laserscope Orion SL Series & KTP /532, KTP:YAG Surgical Lasers (K941841, K933880 & K911830) * Continuum Biomedical Medlite 532 & 1064 nm Surgical Lasers (K952636, K922935 & K922577) Continuum Biomed…
Laserscope1994—
*K933880SL Series Surgical Laser Systems
Summary page 1
…lassification Name: Laser Powered Surgical Instrument (and Accessories). Predicate Devices *» Laserscope Orion SL Series & KTP /532, KTP:YAG Surgical Lasers (K941841, K933880 & K911830) * Continuum Biomedical Medlite 532 & 1064 nm Surgical Lasers (K952636, K922935 & K922577) Continuum Biomedical MedA…
Laserscope1994—
*K911830Laserscope (R) KTP/532 and KTP/Yag Surgical Laser
Summary page 1
…ion Name: Laser Powered Surgical Instrument (and Accessories). Predicate Devices *» Laserscope Orion SL Series & KTP /532, KTP:YAG Surgical Lasers (K941841, K933880 & K911830) * Continuum Biomedical Medlite 532 & 1064 nm Surgical Lasers (K952636, K922935 & K922577) Continuum Biomedical MedAlex 755 nm…
Laserscope1991—
*K952636Medlite Laser System
Summary page 1
…te Devices *» Laserscope Orion SL Series & KTP /532, KTP:YAG Surgical Lasers (K941841, K933880 & K911830) * Continuum Biomedical Medlite 532 & 1064 nm Surgical Lasers (K952636, K922935 & K922577) Continuum Biomedical MedAlex 755 nm Surgical Lasers (K935631) Candela TL-1 Alexandrite Laser (K944090 & K9…
Continuum Biomedical, Inc.1995—
*K922935Conbio-Medlite Q-Switched ND:Yag Laser System
Summary page 1
…s *» Laserscope Orion SL Series & KTP /532, KTP:YAG Surgical Lasers (K941841, K933880 & K911830) * Continuum Biomedical Medlite 532 & 1064 nm Surgical Lasers (K952636, K922935 & K922577) Continuum Biomedical MedAlex 755 nm Surgical Lasers (K935631) Candela TL-1 Alexandrite Laser (K944090 & K940173) P…
Buckman Co., Inc.1993—
*K922577Conbio-Medlite (TM) Q-Switched ND:Yag Laser System
Summary page 1
…scope Orion SL Series & KTP /532, KTP:YAG Surgical Lasers (K941841, K933880 & K911830) * Continuum Biomedical Medlite 532 & 1064 nm Surgical Lasers (K952636, K922935 & K922577) Continuum Biomedical MedAlex 755 nm Surgical Lasers (K935631) Candela TL-1 Alexandrite Laser (K944090 & K940173) Pfizer /Prem…
Continuum Biomedical, Inc.1993—
*K935631Conbio Medalex Laser System
Summary page 1
…841, K933880 & K911830) * Continuum Biomedical Medlite 532 & 1064 nm Surgical Lasers (K952636, K922935 & K922577) Continuum Biomedical MedAlex 755 nm Surgical Lasers (K935631) Candela TL-1 Alexandrite Laser (K944090 & K940173) Pfizer /Premier Centauri & Pegasus 2940 nm Surgical Lasers (K905802 & K9046…
Continuum Biomedical, Inc.1994—
*K944090Candela Alex Lazr Q-Switched Alexandrite Laser
Summary page 1
…dical Medlite 532 & 1064 nm Surgical Lasers (K952636, K922935 & K922577) Continuum Biomedical MedAlex 755 nm Surgical Lasers (K935631) Candela TL-1 Alexandrite Laser (K944090 & K940173) Pfizer /Premier Centauri & Pegasus 2940 nm Surgical Lasers (K905802 & K904627) Continuum Multilite Er:YAG (755 nm) S…
Candela Laser Corp.1994—
*K940173Candela Q-Switched Alexandrite Laser
Summary page 1
…ite 532 & 1064 nm Surgical Lasers (K952636, K922935 & K922577) Continuum Biomedical MedAlex 755 nm Surgical Lasers (K935631) Candela TL-1 Alexandrite Laser (K944090 & K940173) Pfizer /Premier Centauri & Pegasus 2940 nm Surgical Lasers (K905802 & K904627) Continuum Multilite Er:YAG (755 nm) Surgical La…
Candela Laser Corp.1994—
*K905802Centauri/Pegasus
Summary page 1
…nuum Biomedical MedAlex 755 nm Surgical Lasers (K935631) Candela TL-1 Alexandrite Laser (K944090 & K940173) Pfizer /Premier Centauri & Pegasus 2940 nm Surgical Lasers (K905802 & K904627) Continuum Multilite Er:YAG (755 nm) Surgical Laser (K933057) Laserscope SmartScan Fiber Delivery Device for use with…
Pfizer Laser Systems1991—
*K904627Centauri Yag Laser Syst, Ear, Nose , Throat
Summary page 1
…dical MedAlex 755 nm Surgical Lasers (K935631) Candela TL-1 Alexandrite Laser (K944090 & K940173) Pfizer /Premier Centauri & Pegasus 2940 nm Surgical Lasers (K905802 & K904627) Continuum Multilite Er:YAG (755 nm) Surgical Laser (K933057) Laserscope SmartScan Fiber Delivery Device for use with Orion SL…
Pfizer Laser Systems1991—
*K933057Multilite Erbium:Yag Surgical Laser System
Summary page 1
…lexandrite Laser (K944090 & K940173) Pfizer /Premier Centauri & Pegasus 2940 nm Surgical Lasers (K905802 & K904627) Continuum Multilite Er:YAG (755 nm) Surgical Laser (K933057) Laserscope SmartScan Fiber Delivery Device for use with Orion SL Series & KTP/532, KTP:YAG Surgical Lasers (K941841, K933880 &…
Continuum Electro-Optics, Inc.1994—
*K950661Candela 10MM Circular Spot Laser Handpiece
Summary page 1
…artScan Fiber Delivery Device for use with Orion SL Series & KTP/532, KTP:YAG Surgical Lasers (K941841, K933880 & K911830) Candela 10 mm Circular Spot Laser Handpiece (K950661) Coherent Family of Scanner Handpieces for use with Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers (K951812 & K946304) ¢ C…
Candela Laser Corp.1995—
*K951812Modified Coherent Ultrapulse CO2 Surgical Lasers
Summary page 1
…K911830) Candela 10 mm Circular Spot Laser Handpiece (K950661) Coherent Family of Scanner Handpieces for use with Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers (K951812 & K946304) ¢ Cyrus Chess Cool Laser Optics (CLO) Unit for use with Argon (488/514 nm), Argon/Dye (677 nm and 585 nm), and KTP (5…
Lumenis, Inc.1995—
*K946304Coherent Family of CO2 Surgical Laser Scanner Handpieces
Summary page 1
…Candela 10 mm Circular Spot Laser Handpiece (K950661) Coherent Family of Scanner Handpieces for use with Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers (K951812 & K946304) ¢ Cyrus Chess Cool Laser Optics (CLO) Unit for use with Argon (488/514 nm), Argon/Dye (677 nm and 585 nm), and KTP (532 nm) Sur…
Lumenis, Inc.1995—
*K934486Cool Laser Optics (Clo) Unit
Summary page 1
…Lasers (K951812 & K946304) ¢ Cyrus Chess Cool Laser Optics (CLO) Unit for use with Argon (488/514 nm), Argon/Dye (677 nm and 585 nm), and KTP (532 nm) Surgical Lasers (K934486) Product Description The Coherent VersaPulse Aesthetic Surgical Lasers (and its delivery accessories) are intended to be used t…
Cyruschess1994—

Also cleared against K941841: 3 other devices →

What descends from it? (1,152)

See all 1,152

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

NumberDeviceApplicantDecidedDescendants
K972347Modified Coherent Versapulse Aesthetic Surgical LaserLumenis, Inc.19971,142
K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc.20021,046
K050738FT Fiber Optic Delivery SystemsFibertech GmbH2005225
K980389Megabeam Reusable Fiber Optic Handpiece and NeedlesCeram Optec, Inc.19983
K974633Scantech Laser ScannerPhantom Technologies, Inc.19980
K972915Erbium 2000 Laser FamilyPhantom Technologies, Inc.19970

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 16 ancestors has a recall.
  • Of its descendants, K972347 (Lumenis, Inc., 1997) has gone furthest, with 1,142 descendants of its own.
  • 3 other devices also cite its predicate K941841.

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 Coherent VersaPulse Aesthetic Surgical Lasers and the Delivery Accessories that are used with them to deliver 532 nm, 1064 nm and 755 nm laser energy that are indicated for use in surgical applications requiring photothermolysis of soft tissue, and 2940 nm laser energy that is indicted for use in surgical applications requiring excision, incision, ablation, vaporization, and coagulation of soft tissue in medical specialties including: general and plastic surgery; and dermatology.

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 K941841

3 other devices cite the same predicate.

  • K021650Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos LaserQuantel Medical · 2002
  • K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future ModelsAltus Medical, Inc. · 2002
  • K974633Scantech Laser ScannerPhantom Technologies, Inc. · 1998

More from Coherent Medical Group

27 FDA decisions under this applicant name. See the company

  • K963339Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
  • K932981Coherent Versapulse 2.1 Holmium Surgical LasersCoherent Medical Group · 1994
  • K923575Coherent Versapluse 2.1 Holmium Surg. LasersCoherent Medical Group · 1993
  • K932468Novus MultiwavelengthCoherent Medical Group · 1993
  • K930981Acculite (TM) OtoprobeCoherent Medical Group · 1993

Recent decisions in GEX

The GEX category page

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  • 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/K960032 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960032: Coherent Versapulse Aesthetic Surgical Lasers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960032

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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