510(k) Report

510(k) · Cleared

Cleared

Novus Verdi Delivery Systems

K991258510(k) TraditionalCleared May 13, 199930-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 13, 1999 as substantially equivalent to K960867 (B.V. Intl. S.A., 1996) and 3 other predicates after a 30-day review. Its family tree reaches back 1 generation to 1981. 296 later devices descend from it.

Decided
May 13, 1999
Review
30 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K812219 (1981). 4 ancestors in all. 296 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestor2006: 4 descendants cleared2002: 1 descendant cleared2003: 2 descendants cleared2005: 6 descendants cleared2011: 11 descendants cleared2004: 1 descendant cleared2017: 11 descendants cleared2009: 10 descendants cleared2007: 5 descendants cleared2008: 11 descendants cleared2013: 13 descendants cleared2014: 12 descendants cleared2012: 7 descendants cleared2010: 11 descendants cleared2015: 13 descendants cleared2022: 27 descendants cleared2016: 14 descendants cleared2020: 17 descendants cleared2019: 12 descendants cleared2023: 15 descendants cleared2018: 12 descendants cleared2025: 29 descendants cleared2024: 25 descendants cleared2021: 10 descendants cleared2026: 17 descendants clearedK812219 · Model 900S Intraocular Probe · Lumenis, Inc. · 198119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 5 descendants2 generations forward: 22 descendants3 generations forward: 30 descendants4 generations forward: 37 descendants5 generations forward: 50 descendants6 generations forward: 65 descendants7 generations forward: 54 descendants8 generations forward: 28 descendants9 generations forward: 4 descendants10 generations forward: 1 descendant K812219 · Model 900S Intraocular Probe · Lumenis, Inc. · 19810+5+10
  1. Root · 1 generation backK812219 Model 900S Intraocular ProbeLumenis, Inc. · 1981
  2. This deviceK991258 Novus Verdi Delivery SystemsLumenis, Inc. · 1999
  3. Descendant · cites it directly · 225 of its ownK050738 FT Fiber Optic Delivery SystemsFibertech GmbH · 2005 · Recalled
  4. Descendant · 2 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
  5. Descendant · 3 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
  6. Descendant · 4 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
  7. Descendant · 4 generations on · 177 of its ownK090164 Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009

Showing 5 of 296 descendants. See all descendants

Descendants cleared per year

2002: 12003: 22004: 12005: 62006: 42007: 52008: 112009: 102010: 112011: 112012: 72013: 132014: 122015: 132016: 142017: 112018: 122019: 122020: 172021: 102022: 272023: 152024: 252025: 292026: 17
2002high 29 (2025) · low 1 (2002)2026

Most influential descendants

Showing 5 of 296 · See all
  • K050738FT Fiber Optic Delivery SystemsFibertech GmbH · 2005 · cites it directly225descendants
  • K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 2 generations on221descendants
  • K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 3 generations on202descendants
  • K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 4 generations on192descendants
  • K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009 · 4 generations on177descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K812219Model 900S Intraocular ProbeLumenis, Inc.1981—
0 (this device)K991258Novus Verdi Delivery SystemsLumenis, Inc.1999—
+1K050738FT Fiber Optic Delivery SystemsFibertech GmbH20055
+2K060033Profile Multi-Platform SystemSciton, Inc2006—
+3K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008—
+4K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199110
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200320
200410
200560
200640
200750
2008110
2009100
2010110
2011110
201270
2013130
2014120
2015130
2016140
2017110
2018120
2019120
2020170
2021100
2022270
2023150
2024250
2025290
2026170
FIG. 1 — Lineage of K991258, 1981–2026Source: 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? (4)

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
*K960867Frequency Doubled ND:Yag Photocoagulator (Viridis) Frequency Doubled ND:Yag…
Summary page 1
…Frequency-Doubled Nd:YAG Photocoagulator Laser Powered Surgical Instrument and Delivery Device Accessories B. V. International Viridis/Evergreen 532 nm Surgical Laser (K960867); Coherent Medical Group Slit Lamp Adapter System (K913127); Coherent Medical Group Indirect Ophthalmoscope (K885196); Coherent M…
B.V. Intl. S.A.1996—
*K913127Coherent Novus 3000 Argon Photocoagulator
Summary page 1
…gical Instrument and Delivery Device Accessories B. V. International Viridis/Evergreen 532 nm Surgical Laser (K960867); Coherent Medical Group Slit Lamp Adapter System (K913127); Coherent Medical Group Indirect Ophthalmoscope (K885196); Coherent Medical Group Endocoagulation Probe (K812219). The devices…
Coherent Medical Group1991—
*K885196Laser Indirect Ophthalmoscope (Lio)
Summary page 1
…ternational Viridis/Evergreen 532 nm Surgical Laser (K960867); Coherent Medical Group Slit Lamp Adapter System (K913127); Coherent Medical Group Indirect Ophthalmoscope (K885196); Coherent Medical Group Endocoagulation Probe (K812219). The devices that are subject to this Special 510(k) Premarket Notifica…
Coherent Medical Group1989—
*K812219Model 900S Intraocular Probe
Summary page 1
…0867); Coherent Medical Group Slit Lamp Adapter System (K913127); Coherent Medical Group Indirect Ophthalmoscope (K885196); Coherent Medical Group Endocoagulation Probe (K812219). The devices that are subject to this Special 510(k) Premarket Notification are the Coherent Laser Indirect Ophthalmoscope, the…
Lumenis, Inc.1981—

Also cleared against K960867: 3 other devices →

What descends from it? (296)

See all 296

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

NumberDeviceApplicantDecidedDescendants
K050738FT Fiber Optic Delivery SystemsFibertech GmbH2005225
K022181Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesLumenis, Inc.200265
K023464Viridis Twin Ophthalmic PhotocoagulatorQuantel Medical20037
K043236Frequency Doubled ND: Yag Photocoagulator, Model VitraQuantel Medical20056
K062336Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation20061

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 4 ancestors has a recall.
  • Of its descendants, K050738 (Fibertech GmbH, 2005) has gone furthest, with 225 descendants of its own.
  • 3 other devices also cite its predicate K960867.

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?

Clinical Indications with a Slit Lamp Delivery System This system is indicated for use in retinal photocoagulation for the treatment of ophthalmic conditions including: Proliferative Diabetic retinopathy, macular degeneration, and retinal detachment. Clinical Indications with a Laser Indirect Ophthalmoscope Delivery System This system has the same clinical indications as the slit lamp delivery system, but it can only be used for peripheral…

Read the full statement (115 words)

Clinical Indications with a Slit Lamp Delivery System

This system is indicated for use in retinal photocoagulation for the treatment of ophthalmic conditions including: Proliferative Diabetic retinopathy, macular degeneration, and retinal detachment.

Clinical Indications with a Laser Indirect Ophthalmoscope Delivery System

This system has the same clinical indications as the slit lamp delivery system, but it can only be used for peripheral photocoagulation.

Clinical Indications with an Endophotocoagulation (EPCP) Delivery System

The EPCP probe has been designed as a means for intraocular photocoagulation as an adjunct to vitrectomy surgery. Specific indications for use for the EPCP include treatment of complicated rhegmatogenous and tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, and various retinal vascular tumors.

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 K960867

3 other devices cite the same predicate.

  • K043236Frequency Doubled ND: Yag Photocoagulator, Model VitraQuantel Medical · 2005
  • K032357Novus TTX Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2003
  • K023464Viridis Twin Ophthalmic PhotocoagulatorQuantel Medical · 2003

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

  • 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/K991258 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991258: Novus Verdi Delivery Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991258

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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