510(k) · Cleared
ClearedNovus 3000 Laser System and Delivery Devices
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 Nov 15, 2005 as substantially equivalent to K022181 (Lumenis, Inc., 2002) and 5 other predicates after a 62-day review. Its family tree reaches back 4 generations to 1989. 4 later devices descend from it.
- Decided
- Nov 15, 2005
- Review
- 62 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 4 generations to K894841 (1989). 37 ancestors in all, the oldest K812219 (1981). 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 3 generations backK960971 Oculight GLIriderm Div. · 1996
- 2 generations backK020374 Oculight SL/SLXIridex Corp · 2002
- 1 generation backK032357 Novus TTX Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2003
- This deviceK052526 Novus 3000 Laser System and Delivery DevicesLumenis, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK062336 Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation · 2006
- Descendant · cites it directly · 1 of its ownK061025 Accutech Endolite ProbeAccutech Medical Technologies, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK123056 Pascal Laser Indirect OphthalmoscopeTopcon Medical Laser Systems, Inc. (Tmls) · 2012
- Descendant · 2 generations on · 0 of its ownK090281 Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K062336Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation · 2006 · cites it directly1descendant
- K061025Accutech Endolite ProbeAccutech Medical Technologies, Inc. · 2006 · cites it directly1descendant
- K123056Pascal Laser Indirect OphthalmoscopeTopcon Medical Laser Systems, Inc. (Tmls) · 2012 · 2 generations on0descendants
- K090281Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −3 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −2 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| −1 | K032357 | Novus TTX Laser and Delivery Devices with Accessories | Lumenis, Inc. | 2003 | — |
| 0 (this device) | K052526 | Novus 3000 Laser System and Delivery Devices | Lumenis, Inc. | 2005 | — |
| +1 | K062336 | Optimedica Laser Indirect Ophthalmoscope | Optimedica Corporation | 2006 | — |
| +1 | K061025 | Accutech Endolite Probe | Accutech Medical Technologies, Inc. | 2006 | — |
| +2 | K123056 | Pascal Laser Indirect Ophthalmoscope | Topcon Medical Laser Systems, Inc. (Tmls) | 2012 | — |
| +2 | K090281 | Accutech Family of Powerflex Laser Delivery Devices | Accutech Medical Technologies, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 2 | 0 |
| 1984 | 2 | 0 |
| 1986 | 2 | 0 |
| 1989 | 5 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022181 | Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesSummary page 1…Laser Instrument, Surgical, Powered (21 CFR 878.4810, Product Code 79 GEX) Predicate Devices: Novus® Varia (K022 181) Novus® Spectra (K022327) LaserLink Zeiss Slit Lamp Delivery Adapters (LaserLink Z and Z-l000) (K022181, K022327, K032357) L~aser… | 2002 |
| * | K022327 | Novus SpectraSummary page 1…Instrument, Surgical, Powered (21 CFR 878.4810, Product Code 79 GEX) Predicate Devices: Novus® Varia (K022 181) Novus® Spectra (K022327) LaserLink Zeiss Slit Lamp Delivery Adapters (LaserLink Z and Z-l000) (K022181, K022327, K032357) L~aserLink HS Slit Lamp Laser D… | 2002 |
| * | K032357 | Novus TTX Laser and Delivery Devices with AccessoriesSummary page 1…Code 79 GEX) Predicate Devices: Novus® Varia (K022 181) Novus® Spectra (K022327) LaserLink Zeiss Slit Lamp Delivery Adapters (LaserLink Z and Z-l000) (K022181, K022327, K032357) L~aserLink HS Slit Lamp Laser Delivery Adapter (K022327, K032357) Lumenis 1000 Integrated Slit Lamp (K052129) Laser Indirect Oph… | 2003 |
| * | K052129 | Lumenis 1000 Integrated Slit LampSummary page 1…livery Adapters (LaserLink Z and Z-l000) (K022181, K022327, K032357) L~aserLink HS Slit Lamp Laser Delivery Adapter (K022327, K032357) Lumenis 1000 Integrated Slit Lamp (K052129) Laser Indirect Ophthalmoscope (Heine and Keeler models) (K022181, K022327, K032357) Lumenis Acculite Endophotocoagulation Probe… | 2005 |
| Kept off the family tree | K022357 | FDA’s K022357 is Transend 300 ES Guidewire, Model 46-814 & Transend 300 Floppy Guidewire, Model… Our reading of the summary gave K022357, FDA’s number for Transend 300 ES Guidewire, Model 46-814 & Transend 300… (Boston Scientific, Target). Its FDA name has none of the distinctive words the summary uses for the device it names, “Illuminating EndoOcular Probe”. Kept off the family tree. Summary page 1…27, K032357) Lumenis Acculite Endophotocoagulation Probe Delivery System (Acculite Endoprobe/Endokit) (K022181, K022327, K032357) [Iluminating EndoOcular Probe (K022357, K931784) Aspirating EndoOcular Probe (K022357, K93 1072) Lumenis's Novus® 3000 Laser System and Delivery Devices is substantial… | 2002 |
| * | K931784 | HGM Illuminating Imaging Endocular ProbeSummary page 1…57) Lumenis Acculite Endophotocoagulation Probe Delivery System (Acculite Endoprobe/Endokit) (K022181, K022327, K032357) [Iluminating EndoOcular Probe (K022357, K931784) Aspirating EndoOcular Probe (K022357, K93 1072) Lumenis's Novus® 3000 Laser System and Delivery Devices is substantially equiva… | 1994 |
| * | K931072 | HGM Illuminating/Aspirating Endoocular ProbeSummary page 1…Delivery System (Acculite Endoprobe/Endokit) (K022181, K022327, K032357) [Iluminating EndoOcular Probe (K022357, K931784) Aspirating EndoOcular Probe (K022357, K93 1072) Lumenis's Novus® 3000 Laser System and Delivery Devices is substantially equivalent to the Lumenis Novus® Varia and the Lumenis… | 1994 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 37 ancestors has a recall of any class.
- Of its descendants, K062336 (Optimedica Corporation, 2006) has gone furthest, with 1 descendant of its own.
- 13 other devices also cite its predicate K022181.
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 3000 Laser System is intended for use in the treatment of ocular pathology. The Novus 3000 Laser System 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…
Read the full statement (335 words)
The Novus 3000 Laser System is intended for use in the treatment of ocular pathology. The Novus 3000 Laser System 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, 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 the delivery of laser energy in eyes with retinal pathology. The Laser Indirect Ophthalmoscope is indicated for use in the following ophthalmic treatments and conditions: diabetic retinopathy (panretinal photocoagulation); peripheral neovascularization, retinal breaks, detachments, and tears, lattice degeneration, pneumatic retinopexy reattachment procedures, segmental peripheral photocoagulation; segmental photocoagulation; cloudy vitreous cavities; pediatric retinal repairs (under general anesthesia), delivery of laser energy through small pupils or to eyes with focal lens opacities.
Endophotocoagulation
When used with a Novus 3000 Laser System, the Acculite EndoOcular Probes (Acculite EndoOcular Probe, Acculite Aspirating EndoOcular Probe, and Acculite Illuminating EndoOcular Probe) are intended 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.
The laser delivery function of the Acculite Acculite EndoOcular Probes (Acculite EndoOcular Probe, Acculite Aspirating EndoOcular Probe and Acculite Illuminating EndoOcular Probe) is indicated for use in ocular surgery to deliver laser energy to the treatment area selected by the surgeon.
The aspiration function of the Acculite Aspirating EndoOcular Probe is indicated for use when unwanted fluid is present in the eye during ocular surgery, causing refraction or scattering of the laser beam from the intended treatment site.
The illumination function of the Acculite Illuminating EndoOcular Probe is indicated for use during ocular surgery to illuminate the interior of the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052526: Novus 3000 Laser System and Delivery Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052526
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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