510(k) · Cleared
ClearedNovus TTX 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 9, 2003 as substantially equivalent to K020374 (Iridex Corp, 2002) and 10 other predicates after a 71-day review. Its family tree reaches back 3 generations to 1989. 5 later devices descend from it.
- Decided
- Oct 9, 2003
- Review
- 71 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 3 generations to K894841 (1989). 30 ancestors in all, the oldest K812219 (1981). 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 2 generations backK960971 Oculight GLIriderm Div. · 1996
- 1 generation backK020374 Oculight SL/SLXIridex Corp · 2002
- This deviceK032357 Novus TTX Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2003
- Descendant · cites it directly · 4 of its ownK052526 Novus 3000 Laser System and Delivery DevicesLumenis, Inc. · 2005
- Descendant · 2 generations on · 1 of its ownK062336 Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation · 2006
- Descendant · 2 generations on · 1 of its ownK061025 Accutech Endolite ProbeAccutech Medical Technologies, Inc. · 2006
- Descendant · 3 generations on · 0 of its ownK123056 Pascal Laser Indirect OphthalmoscopeTopcon Medical Laser Systems, Inc. (Tmls) · 2012
- Descendant · 3 generations on · 0 of its ownK090281 Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc. · 2009
Most influential descendants
Showing 5 of 5 · See all- K052526Novus 3000 Laser System and Delivery DevicesLumenis, Inc. · 2005 · cites it directly4descendants
- K062336Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation · 2006 · 2 generations on1descendant
- K061025Accutech Endolite ProbeAccutech Medical Technologies, Inc. · 2006 · 2 generations on1descendant
- K123056Pascal Laser Indirect OphthalmoscopeTopcon Medical Laser Systems, Inc. (Tmls) · 2012 · 3 generations on0descendants
- K090281Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc. · 2009 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −2 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −1 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| 0 (this device) | K032357 | Novus TTX Laser and Delivery Devices with Accessories | Lumenis, Inc. | 2003 | — |
| +1 | K052526 | Novus 3000 Laser System and Delivery Devices | Lumenis, Inc. | 2005 | — |
| +2 | K062336 | Optimedica Laser Indirect Ophthalmoscope | Optimedica Corporation | 2006 | — |
| +2 | K061025 | Accutech Endolite Probe | Accutech Medical Technologies, Inc. | 2006 | — |
| +3 | K123056 | Pascal Laser Indirect Ophthalmoscope | Topcon Medical Laser Systems, Inc. (Tmls) | 2012 | — |
| +3 | 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 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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? (12)
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 |
|---|---|---|---|
| * | K020374 | Oculight SL/SLXSummary page 1…urgery Panel GEX, Laser powered surgical instrument 111. Predicate Devices Iris Medica1 Oculight SUSLx (K020374, K913430, K912918) Nidek DC-3300 (KO13760) Nidek DC-3000 (K903639) BV International… | 2002 |
| * | K913430 | Iris Oculight (R) SLXSummary page 1…nel GEX, Laser powered surgical instrument 111. Predicate Devices Iris Medica1 Oculight SUSLx (K020374, K913430, K912918) Nidek DC-3300 (KO13760) Nidek DC-3000 (K903639) BV International Viridis L… | 1991 |
| * | K912918 | Iris Oculight Diode Laser Adding Slit Lamp AdapterSummary page 1…GEX, Laser powered surgical instrument 111. Predicate Devices Iris Medica1 Oculight SUSLx (K020374, K913430, K912918) Nidek DC-3300 (KO13760) Nidek DC-3000 (K903639) BV International Viridis Laser (K96… | 1991 |
| * | K013760 | DC-3300 Laser Diode Photocoagulator | 2002 |
| * | K903639 | Nidek DC-3000 Diode Laser PhotocoagulatorSummary page 1…111. Predicate Devices Iris Medica1 Oculight SUSLx (K020374, K913430, K912918) Nidek DC-3300 (KO13760) Nidek DC-3000 (K903639) BV International Viridis Laser (K960867) Coherent System 920 Argon/Krypton (K830235)… | 1991 |
| * | K960867 | Frequency Doubled ND:Yag Photocoagulator (Viridis) Frequency Doubled ND:Yag…Summary page 1…1 Oculight SUSLx (K020374, K913430, K912918) Nidek DC-3300 (KO13760) Nidek DC-3000 (K903639) BV International Viridis Laser (K960867) Coherent System 920 Argon/Krypton (K830235) Novus Varia Ophthalmic Laser (KO22 181)… | 1996 |
| * | K830235 | Franzen Needle GuideSummary page 1…Nidek DC-3300 (KO13760) Nidek DC-3000 (K903639) BV International Viridis Laser (K960867) Coherent System 920 Argon/Krypton (K830235) Novus Varia Ophthalmic Laser (KO22 181) LaserLink 2, LaserLink 2-1000 (K022181) Las… | 1983 |
| * | K022181 | Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesSummary page 1…(K960867) Coherent System 920 Argon/Krypton (K830235) Novus Varia Ophthalmic Laser (KO22 181) LaserLink 2, LaserLink 2-1000 (K022181) LaserLink HS (K973470) Iridex Large Spot Slit Lamp Delivery Adapters (K020374) Nide… | 2002 |
| * | K973470 | Coherent Popeye Ophthalmic Laser System, Coherent Popeye Ophthalmic Laser System in…Summary page 1…em 920 Argon/Krypton (K830235) Novus Varia Ophthalmic Laser (KO22 181) LaserLink 2, LaserLink 2-1000 (K022181) LaserLink HS (K973470) Iridex Large Spot Slit Lamp Delivery Adapters (K020374) Nidek Slit Lamp Delivery Adapter for Nidek… | 1997 |
| * | K840590 | Fleischman-Swartz Endo-Ocular ProbeSummary page 1…K020374) Acculite Endophotocoagulation Probe Delivery System (Acculite Endoprobe/Endokit) (KO22 18 1); e HGM EndoOcular Probe (K840590, K860358) 0 Iris Medical Endoprobe (K020374, K96097) IV. Product Description The Novus TTx Lase… | 1984 |
| * | K860358 | Fleischman-Swartz Endo-Ocular Probe (Sterile)Summary page 1…Acculite Endophotocoagulation Probe Delivery System (Acculite Endoprobe/Endokit) (KO22 18 1); e HGM EndoOcular Probe (K840590, K860358) 0 Iris Medical Endoprobe (K020374, K96097) IV. Product Description The Novus TTx Laser is an a… | 1986 |
| Kept off the family tree | K960097 | FDA’s K960097 is Chartr EP Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1997 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052526 | Novus 3000 Laser System and Delivery Devices | 2005 | 4 |
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 14 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 30 ancestors has a recall of any class.
- Of its descendants, K052526 (Lumenis, Inc., 2005) has gone furthest, with 4 descendants of its own.
- 8 other devices also cite its predicate K020374.
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 TTx Laser and Delivery Devices is intended for use in the treatment of ocular pathology. The Novus TTx 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: - Diabetic retinopathy (proliferative retinopathy, nonproliferative retinopathy…
Read the full statement (184 words)
The Novus TTx Laser and Delivery Devices is intended for use in the treatment of ocular pathology. The Novus TTx 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:
- Diabetic retinopathy (proliferative retinopathy, nonproliferative retinopathy, macular edema);
- Retinal tears, detachments and holes
- Lattice degeneration
- Age-related macular degeneration
- Intraocular tumors (choroidal hemangioma, choroidal melanoma, retinoblastoma)
- retinopathy of prematurity
- choroidal neovascularization;
- central and branch retinal vein occlusion;
Iridotorny, iridectomy and trabeculoplasty in angle closure glaucoma and openangle 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/K032357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032357: Novus TTX 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/K032357
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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