510(k) · Cleared
ClearedNovus Varia Ophthalmic Laser and Delivery Devices with Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Oct 1, 2002 as substantially equivalent to K932468 (Coherent Medical Group, 1993) and 6 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1989. 65 later devices descend from it.
- Decided
- Oct 1, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 2 generations to K894841 (1989). 11 ancestors in all, the oldest K812219 (1981). 65 later devices descend from it, 14 citing it directly.
- Root · 2 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 1 generation backK960971 Oculight GLIriderm Div. · 1996
- This deviceK022181 Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2002
- Descendant · cites it directly · 29 of its ownK043486 Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005
- Descendant · 2 generations on · 23 of its ownK091666 Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009
- Descendant · 3 generations on · 22 of its ownK092621 Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009
- Descendant · 2 generations on · 17 of its ownK081744 Pascal Synthesis Delivery SystemOptimedica Corporation · 2008
- Descendant · 4 generations on · 16 of its ownK100019 Pascal Streamline PhotocoagulatorOptimedica Corporation · 2010 · Recalled
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K043486Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005 · cites it directly29descendants
- K091666Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009 · 2 generations on23descendants
- K092621Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009 · 3 generations on22descendants
- K081744Pascal Synthesis Delivery SystemOptimedica Corporation · 2008 · 2 generations on17descendants
- K100019Pascal Streamline PhotocoagulatorOptimedica Corporation · 2010 · 4 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −1 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| 0 (this device) | K022181 | Novus Varia Ophthalmic Laser and Delivery Devices with Accessories | Lumenis, Inc. | 2002 | — |
| +1 | K043486 | Pascal Photocoagulator, Product-Pascal-01 | Topcon Medical Laser Systems, Inc. | 2005 | — |
| +2 | K091666 | Pascal Photocoagulator, Pascal-US | Optimedica Corporation | 2009 | — |
| +3 | K092621 | Pascal Streamline Photocoagulator | Topcon Medical Laser Systems, Inc. | 2009 | — |
| +2 | K081744 | Pascal Synthesis Delivery System | Optimedica Corporation | 2008 | — |
| +4 | K100019 | Pascal Streamline Photocoagulator | Optimedica Corporation | 2010 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
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 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K932468 | Novus MultiwavelengthSummary page 1…Laser and Delivery Devices Primary Classification Name: 111. Predicate Devices Novus Omni Laser System (K932468) Iris Medical Oculight GL and Delivery Devices (K96097 1) Ultima 2000AJltima 2000SE (K913127) Coherent… | 1993 |
| * | K960971 | Oculight GLSummary page 1…Devices Primary Classification Name: 111. Predicate Devices Novus Omni Laser System (K932468) Iris Medical Oculight GL and Delivery Devices (K96097 1) Ultima 2000AJltima 2000SE (K913127) Coherent System 920 ArgodKrypton Laser (K837235) LaserLink Z Slit… | 1996 |
| * | K913127 | Coherent Novus 3000 Argon PhotocoagulatorSummary page 1…111. Predicate Devices Novus Omni Laser System (K932468) Iris Medical Oculight GL and Delivery Devices (K96097 1) Ultima 2000AJltima 2000SE (K913127) Coherent System 920 ArgodKrypton Laser (K837235) LaserLink Z Slit Lamp Laser Delivery Adapter (LaserLink Z & L… | 1991 |
| * | K837235 | Model 920 Argon Laser SystemSummary page 1…(K932468) Iris Medical Oculight GL and Delivery Devices (K96097 1) Ultima 2000AJltima 2000SE (K913127) Coherent System 920 ArgodKrypton Laser (K837235) LaserLink Z Slit Lamp Laser Delivery Adapter (LaserLink Z & LaserLink 2-1OOO) (K000498, K991258, K932468)… | 1983 |
| * | K000498 | Coherent Laserlink Z-1000 Slit Lamp Laser Delivery AdapterSummary page 1…00SE (K913127) Coherent System 920 ArgodKrypton Laser (K837235) LaserLink Z Slit Lamp Laser Delivery Adapter (LaserLink Z & LaserLink 2-1OOO) (K000498, K991258, K932468) Acculite Endophotocoagulation Probe Delivery System (K99 1258, K932468, K9 13127) L… | 2000 |
| * | K991258 | Novus Verdi Delivery SystemsSummary page 1…3127) Coherent System 920 ArgodKrypton Laser (K837235) LaserLink Z Slit Lamp Laser Delivery Adapter (LaserLink Z & LaserLink 2-1OOO) (K000498, K991258, K932468) Acculite Endophotocoagulation Probe Delivery System (K99 1258, K932468, K9 13127) Laser Indi… | 1999 |
| * | K885196 | Laser Indirect Ophthalmoscope (Lio)Summary page 1…8) Acculite Endophotocoagulation Probe Delivery System (K99 1258, K932468, K9 13127) Laser Indirect Ophthalmoscope (K991258, K932468, K913127, K885196) IV. Product Description The Novus Varia Laser System is an air cooled, diode-pumped, solid state, Nd:YAG, three-… | 1989 |
What descends from it? (65)
See all 6514 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043486 | Pascal Photocoagulator, Product-Pascal-01 | 2005 | 29 |
| K042785 | Multi Color Laser Photocoagulator, Model MC-300 | 2004 | 15 |
| K081704 | Selecta Family of Ophithalmic Laser Systems | 2008 | 9 |
| K052129 | Lumenis 1000 Integrated Slit Lamp | 2005 | 5 |
| K032357 | Novus TTX Laser and Delivery Devices with Accessories | 2003 | 5 |
| K052526 | Novus 3000 Laser System and Delivery Devices | 2005 | 4 |
| K103547 | Lightlas Multi-Wavelength Medical Laser System | 2011 | 2 |
| K111213 | Vision One Laser System | 2011 | 1 |
| K072514 | Visulas Trion | 2007 | 1 |
| K062336 | Optimedica Laser Indirect Ophthalmoscope | 2006 | 1 |
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 13 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K043486 (Topcon Medical Laser Systems, Inc., 2005) has gone furthest, with 29 descendants of its own.
- 1 other device also cites its predicate K932468.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The Novus Varia Ophthalmic Laser and Delivery Devices is intended for use in the treatment of ocular pathology. The Lumenis Varia is indicated for use in photocoagulation of both anterior and posterior segments including: Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: - proliferative and nonproliferative diabetic retinopathy; -…
Read the full statement (169 words)
The Novus Varia Ophthalmic Laser and Delivery Devices is intended for use in the treatment of ocular pathology. The Lumenis Varia is indicated for use in photocoagulation of both anterior and posterior segments including:
Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
- proliferative and nonproliferative diabetic retinopathy;
- choroidal neovascularization;
- branch retinal vein occlusion;
- age-related macular degeneration
- retinal tears and detachments
- retinopathy of prematurity
Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma
Laser Indirect Ophthalmoscope
The Laser Indirect Ophthalmoscope is indicated for use in the following ophthalmic treatments: diabetic retinopathy (panretinal photocoagulation); retinopexy; segmental peripheral photocoagulation; segmental photocoagulation; cloudy vitreous cavities; and, pediatric retinal repairs (under general anesthesia)
Endophotocoagulation
The Acculite Endoprobe is indicated for use in the following ophthalmic applications: photocoagulation of the anterior and posterior segment, including: anterior segment treatment in the surgical management of glaucoma; endophotocoagulation in vitreoretinal surgery, including panretinal photocoagulation, retinopexy, and treatment of neovascularization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022181: Novus Varia Ophthalmic Laser and Delivery Devices with Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022181
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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