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 Nov 22, 2016 as substantially equivalent to K141851 (Od-Os GmbH, 2015) after a 110-day review. Its family tree reaches back 11 generations to 1989. 1 later device descends from it.
- Decided
- Nov 22, 2016
- Review
- 110 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K894841 (1989). 43 ancestors in all, the oldest K812219 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 7 generations between
- 3 generations backK121475 Txcell Scanning Laser Delivery SystemIridex Corp · 2012
- 2 generations backK123542 Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc. · 2013 · Recalled
- 1 generation backK141851 Navilas Laser SystemOd-Os GmbH · 2015
- This deviceK162191 NAVILAS Laser SystemOd-Os GmbH · 2016
- Descendant · cites it directly · 0 of its ownK251772 Navilas Laser System 577sl (156691)Od-Os GmbH · 2025
Show all 11 generations
- Root · 11 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 10 generations backK960971 Oculight GLIriderm Div. · 1996
- 9 generations backK020374 Oculight SL/SLXIridex Corp · 2002
- 8 generations backK043486 Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005
- 7 generations backK091666 Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009
- 6 generations backK092621 Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009
- 5 generations backK100019 Pascal Streamline PhotocoagulatorOptimedica Corporation · 2010 · Recalled
- 4 generations backK111108 Pascal Streamline 577 (with Accessories)Topcon Medical Laser Systems, Inc. · 2011
- 3 generations backK121475 Txcell Scanning Laser Delivery SystemIridex Corp · 2012
- 2 generations backK123542 Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc. · 2013 · Recalled
- 1 generation backK141851 Navilas Laser SystemOd-Os GmbH · 2015
- This deviceK162191 NAVILAS Laser SystemOd-Os GmbH · 2016
Most influential descendants
Showing 1 of 1 · See all- K251772Navilas Laser System 577sl (156691)Od-Os GmbH · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −10 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −9 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| −8 | K043486 | Pascal Photocoagulator, Product-Pascal-01 | Topcon Medical Laser Systems, Inc. | 2005 | — |
| −7 | K091666 | Pascal Photocoagulator, Pascal-US | Optimedica Corporation | 2009 | — |
| −6 | K092621 | Pascal Streamline Photocoagulator | Topcon Medical Laser Systems, Inc. | 2009 | — |
| −5 | K100019 | Pascal Streamline Photocoagulator | Optimedica Corporation | 2010 | 1 |
| −4 | K111108 | Pascal Streamline 577 (with Accessories) | Topcon Medical Laser Systems, Inc. | 2011 | — |
| −3 | K121475 | Txcell Scanning Laser Delivery System | Iridex Corp | 2012 | — |
| −2 | K123542 | Pascal Synthesis (532NM/577NM) Opthalmic Laser | Topcon Medical Laser Systems, Inc. | 2013 | 1 |
| −1 | K141851 | Navilas Laser System | Od-Os GmbH | 2015 | — |
| 0 (this device) | K162191 | NAVILAS Laser System | Od-Os GmbH | 2016 | — |
| +1 | 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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K141851 | Navilas Laser SystemSummary page 5…510(K) SUMMARY SUBSTANTIAL EQUIVALENCE The Navilas Laser System 577s is substantially equivalent to the Navilas Laser System 577+ cleared under K141851. This laser model is functionally identical to the predicate Navilas laser, the same scientific technology as well as same… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251772 | Navilas Laser System 577sl (156691) | 2025 | 0 |
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 27 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 43 ancestors have a recall of any class.
- Of its descendants, K251772 (Od-Os GmbH, 2025) has gone furthest, with 0 descendants 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. 2016, 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 577s is 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…
Read the full statement (115 words)
The Navilas Laser System 577s is 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 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/K162191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162191: 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/K162191
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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