510(k) Report

510(k) · Cleared

Cleared

Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag Lasers

K980685510(k) TraditionalCleared May 20, 199886-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

Lumenis, Inc. · GEX Powered Laser Surgical Instrument

Cleared on May 20, 1998 as substantially equivalent to K960413 (Lumenis, Inc., 1996) and 8 other predicates after an 86-day review. Its family tree reaches back 2 generations to 1990. 351 later devices descend from it.

Decided
May 20, 1998
Review
86 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
9

Its longest line of descent runs back 2 generations to K902990 (1990). 10 ancestors in all, the oldest K895518 (1989). 351 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 2 other ancestors1993: 1 other ancestor1992: 2 other ancestors1991: 2 other ancestors1989: 1 other ancestor1999: 1 descendant cleared2001: 2 descendants cleared2002: 8 descendants cleared2005: 4 descendants cleared2014: 15 descendants cleared2013: 21 descendants cleared2009: 4 descendants cleared2008: 9 descendants cleared2012: 18 descendants cleared2016: 26 descendants cleared2006: 3 descendants cleared2010: 12 descendants cleared2015: 15 descendants cleared2007: 1 descendant cleared2024: 20 descendants cleared2011: 13 descendants cleared2021: 15 descendants cleared2017: 16 descendants cleared2022: 19 descendants cleared2018: 15 descendants cleared2003: 3 descendants cleared2004: 3 descendants cleared2020: 20 descendants cleared2019: 11 descendants cleared2026: 25 descendants cleared2023: 20 descendants cleared2025: 32 descendants clearedK902990 · Coherent Holmium:Yag Surgical Laser · Coherent Medical Division · 1990K960413 · Coherent Slimline Single Lumen Aspiration Needle Kit · Lumenis, Inc. · 19961990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 21 descendants4 generations forward: 29 descendants5 generations forward: 45 descendants6 generations forward: 46 descendants7 generations forward: 49 descendants8 generations forward: 43 descendants9 generations forward: 42 descendants10 generations forward: 29 descendants11 generations forward: 16 descendants12 generations forward: 8 descendants13 generations forward: 7 descendants14 generations forward: 1 descendant15 generations forward: 2 descendants16 generations forward: 4 descendants17 generations forward: 2 descendants18 generations forward: 1 descendant K960413 · Coherent Slimline Single Lumen Aspiration Needle Kit · Lumenis, Inc. · 1996K902990 · Coherent Holmium:Yag Surgical Laser · Coherent Medical Division · 19900+5+10+15
  1. Root · 2 generations backK902990 Coherent Holmium:Yag Surgical LaserCoherent Medical Division · 1990
  2. 1 generation backK960413 Coherent Slimline Single Lumen Aspiration Needle KitLumenis, Inc. · 1996
  3. This deviceK980685 Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag LasersLumenis, Inc. · 1998
  4. Descendant · cites it directly · 350 of its ownK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
  5. Descendant · 2 generations on · 342 of its ownK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
  6. Descendant · 3 generations on · 136 of its ownK083616 Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc. · 2009
  7. Descendant · 3 generations on · 136 of its ownK083215 Incisive Family of Inpulse ND:Yag LasersIncisive, LLC · 2009
  8. Descendant · 4 generations on · 122 of its ownK093545 Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC) · 2010

Showing 5 of 351 descendants. See all descendants

Descendants cleared per year

1999: 12001: 22002: 82003: 32004: 32005: 42006: 32007: 12008: 92009: 42010: 122011: 132012: 182013: 212014: 152015: 152016: 262017: 162018: 152019: 112020: 202021: 152022: 192023: 202024: 202025: 322026: 25
1999high 32 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 351 · See all
  • K990947Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND…Lumenis, Inc. · 1999 · cites it directly350descendants
  • K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Lumenis · 2001 · 2 generations on342descendants
  • K083616Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc. · 2009 · 3 generations on136descendants
  • K083215Incisive Family of Inpulse ND:Yag LasersIncisive, LLC · 2009 · 3 generations on136descendants
  • K093545Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC) · 2010 · 4 generations on122descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K902990Coherent Holmium:Yag Surgical LaserCoherent Medical Division1990—
−1K960413Coherent Slimline Single Lumen Aspiration Needle KitLumenis, Inc.1996—
0 (this device)K980685Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag LasersLumenis, Inc.1998—
+1K990947Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO…Lumenis, Inc.1999—
+2K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis20012
+3K083616Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc.2009—
+3K083215Incisive Family of Inpulse ND:Yag LasersIncisive, LLC2009—
+4K093545Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC)2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199120
199220
199310
199420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200120
200280
200330
200430
200540
200630
200710
200890
200940
2010120
2011130
2012180
2013210
2014150
2015150
2016260
2017160
2018150
2019110
2020200
2021150
2022190
2023200
2024200
2025320
2026250
FIG. 1 — Lineage of K980685, 1990–2026Source: 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? (9)

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
*K960413Coherent Slimline Single Lumen Aspiration Needle Kit
Summary page 1
…ed Surgical Instrument (and Accessories). Predicate Devices Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K960413, K933318, K932981, K923575, K914991, K914136, K910037, K902990, and K895518) Product Description The modified Coherent VersaPul…
Lumenis, Inc.1996—
*K933318Coherent Versapulse 2.1U /1.06U Compact Surgical Laser, Models a & B
Summary page 1
…al Instrument (and Accessories). Predicate Devices Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K960413, K933318, K932981, K923575, K914991, K914136, K910037, K902990, and K895518) Product Description The modified Coherent VersaPulse Select…
Lumenis, Inc.1994—
*K932981Coherent Versapulse 2.1 Holmium Surgical Lasers
Summary page 1
…ment (and Accessories). Predicate Devices Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K960413, K933318, K932981, K923575, K914991, K914136, K910037, K902990, and K895518) Product Description The modified Coherent VersaPulse Select Single W…
Coherent Medical Group1994—
*K923575Coherent Versapluse 2.1 Holmium Surg. Lasers
Summary page 1
…Accessories). Predicate Devices Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K960413, K933318, K932981, K923575, K914991, K914136, K910037, K902990, and K895518) Product Description The modified Coherent VersaPulse Select Single Wavelength…
Coherent Medical Group1993—
*K914991Versapulse (TM) Twopointone/XE Holmium Surg Lasers
Summary page 1
…ies). Predicate Devices Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K960413, K933318, K932981, K923575, K914991, K914136, K910037, K902990, and K895518) Product Description The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG)…
Coherent Medical Group1992—
*K914136Coherent Versapulse (TM) 2.1XE/2.1L Holmi Surg Lase
Summary page 1
…edicate Devices Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K960413, K933318, K932981, K923575, K914991, K914136, K910037, K902990, and K895518) Product Description The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual…
Coherent Medical Group1992—
*K910037Coherent Holmium:Yag Surgical Laser
Summary page 1
…evices Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K960413, K933318, K932981, K923575, K914991, K914136, K910037, K902990, and K895518) Product Description The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Waveleng…
Coherent Medical Group1991—
*K902990Coherent Holmium:Yag Surgical Laser
Summary page 1
…Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K960413, K933318, K932981, K923575, K914991, K914136, K910037, K902990, and K895518) Product Description The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YA…
Coherent Medical Division1990—
*K895518Coherent Holmium:Yag Surgical Laser
Summary page 1
…aPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K960413, K933318, K932981, K923575, K914991, K914136, K910037, K902990, and K895518) Product Description The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Sur…
Lumenis, Inc.1989—

Also cleared against K960413: 3 other devices →

What descends from it? (351)

See all 351

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

NumberDeviceApplicantDecidedDescendants
K990947Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND…Lumenis, Inc.1999350

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 8 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
  • None of the 10 ancestors has a recall.
  • Of its descendants, K990947 (Lumenis, Inc., 1999) has gone furthest, with 350 descendants of its own.
  • 3 other devices also cite its predicate K960413.

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 modified and the currently marketed Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers are intended for use in endoscopic holmium laser resection of the prostate (HoLRP) for treatment of benign prostatic hypertrophy (BPH).

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 K960413

3 other devices cite the same predicate.

  • K050738FT Fiber Optic Delivery SystemsFibertech GmbH · 20055 recalls
  • K990947Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND: Yag Surgical Lasers…Lumenis, Inc. · 1999
  • K980838Reusable Megabeam Fiber Optic Delivery SystemCeram Optec, Inc. · 1998

More from Lumenis, Inc.

47 FDA decisions under this applicant name. See the company

  • K211979Lumenis Y&R Laser SystemLumenis, Inc. · 2022
  • K151109Lumenis Smart532 Laser SystemLumenis, Inc. · 2015
  • K130195Scanning LaserlinkLumenis, Inc. · 20131 recall
  • K111213Vision One Laser SystemLumenis, Inc. · 20111 recall
  • K100228Versapulse Model P20 Laser SystemLumenis, Inc. · 2010

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/K980685 · printed Nov 5, 2026

Cite this page

510(k) Report. “K980685: Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag Lasers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980685

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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