510(k) · Cleared
ClearedNavilas Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Od-Os GmbH · GEX Powered Laser Surgical Instrument
Cleared on Jan 2, 2015 as substantially equivalent to K091064 (Od-Os GmbH, 2009) and 3 other predicates after a 177-day review. Its family tree reaches back 10 generations to 1989. 2 later devices descend from it.
- Decided
- Jan 2, 2015
- Review
- 177 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K894841 (1989). 42 ancestors in all, the oldest K812219 (1981). 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 6 generations between
- 3 generations backK111108 Pascal Streamline 577 (with Accessories)Topcon Medical Laser Systems, Inc. · 2011
- 2 generations backK121475 Txcell Scanning Laser Delivery SystemIridex Corp · 2012
- 1 generation backK123542 Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc. · 2013 · Recalled
- This deviceK141851 Navilas Laser SystemOd-Os GmbH · 2015
- Descendant · cites it directly · 1 of its ownK162191 NAVILAS Laser SystemOd-Os GmbH · 2016
- Descendant · 2 generations on · 0 of its ownK251772 Navilas Laser System 577sl (156691)Od-Os GmbH · 2025
Show all 10 generations
- Root · 10 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 9 generations backK960971 Oculight GLIriderm Div. · 1996
- 8 generations backK020374 Oculight SL/SLXIridex Corp · 2002
- 7 generations backK043486 Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005
- 6 generations backK091666 Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009
- 5 generations backK092621 Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009
- 4 generations backK100019 Pascal Streamline PhotocoagulatorOptimedica Corporation · 2010 · Recalled
- 3 generations backK111108 Pascal Streamline 577 (with Accessories)Topcon Medical Laser Systems, Inc. · 2011
- 2 generations backK121475 Txcell Scanning Laser Delivery SystemIridex Corp · 2012
- 1 generation backK123542 Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc. · 2013 · Recalled
- This deviceK141851 Navilas Laser SystemOd-Os GmbH · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −9 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −8 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| −7 | K043486 | Pascal Photocoagulator, Product-Pascal-01 | Topcon Medical Laser Systems, Inc. | 2005 | — |
| −6 | K091666 | Pascal Photocoagulator, Pascal-US | Optimedica Corporation | 2009 | — |
| −5 | K092621 | Pascal Streamline Photocoagulator | Topcon Medical Laser Systems, Inc. | 2009 | — |
| −4 | K100019 | Pascal Streamline Photocoagulator | Optimedica Corporation | 2010 | 1 |
| −3 | K111108 | Pascal Streamline 577 (with Accessories) | Topcon Medical Laser Systems, Inc. | 2011 | — |
| −2 | K121475 | Txcell Scanning Laser Delivery System | Iridex Corp | 2012 | — |
| −1 | K123542 | Pascal Synthesis (532NM/577NM) Opthalmic Laser | Topcon Medical Laser Systems, Inc. | 2013 | 1 |
| 0 (this device) | K141851 | Navilas Laser System | Od-Os GmbH | 2015 | — |
| +1 | K162191 | NAVILAS Laser System | Od-Os GmbH | 2016 | — |
| +2 | K251772 | Navilas Laser System 577sl (156691) | Od-Os GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2025 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K091064 | Navilas Laser SystemSummary page 5…PREDICATE DEVICES FOR NAVILAS LASER SYSTEM 510(K) # TRADE NAME MANUFACTURER K091064 Navilas Laser System OD-OS PASCAL® Synthesis Ophthalmic… | 2009 |
| * | K123542 | Pascal Synthesis (532NM/577NM) Opthalmic LaserSummary page 5…NUFACTURER K091064 Navilas Laser System OD-OS PASCAL® Synthesis Ophthalmic K123542 Topcon Medical Systems Scanning Laser System… | 2013 |
| * | K071687 | Famili of Iridex IQ Laser SystemsSummary page 5…lmic K123542 Topcon Medical Systems Scanning Laser System K071687 Iridex IQ Family Iridex PREDICATE DEVICES FOR NAVILAS LASER… | 2008 |
| * | K091581 | Supra 577.Y LaserSummary page 5…ical Systems Scanning Laser System K071687 Iridex IQ Family Iridex K091581 Quantel Supra 577 Quantel 4.4 DEVICE DESCRIPTION The NAVILAS Laser System combines… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162191 | NAVILAS Laser System | 2016 | 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 26 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 42 ancestors have a recall of any class.
- Of its descendants, K162191 (Od-Os GmbH, 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 Navilas Laser System/Navilas Laser System 532+/ Navilas Laser System 577+ are indicated for use: • In Retinal Photocoagulation for the treatment of Clinically Significant Diabetic Macular Edema (Focal or Grid Laser), Proliferative Diabetic Retinopathy (Panretinal Photocoagulation), Sub-retinal (Choroidal) Neovascularization (Focal Laser), Central and Branch Retinal Vein Occlusion (Scatter Laser Photocoagulation, Focal or Grid Laser), Lattice…
Read the full statement (123 words)
The Navilas Laser System/Navilas Laser System 532+/ Navilas Laser System 577+ are indicated for use:
• In Retinal Photocoagulation for the treatment of Clinically Significant Diabetic Macular Edema (Focal or Grid Laser), Proliferative Diabetic Retinopathy (Panretinal Photocoagulation), Sub-retinal (Choroidal) Neovascularization (Focal Laser), Central and Branch Retinal Vein Occlusion (Scatter Laser Photocoagulation, Focal or Grid Laser), Lattice Degeneration, Retinal Tears and Detachments (Laser Retinopexy).
• For the imaging (capture, display, storage and manipulation) of the retina of the eye, including via color, fluorescein angiography and infrared imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segment of the eye.
• In Laser Trabeculoplasty for Primary Open Angle Glaucoma, as well as Iridotomy and Iridoplasty for Closed Angle Glaucoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141851: Navilas Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141851
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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