510(k) · Cleared

Cleared

Navilas Laser System

K091064510(k) TraditionalCleared Oct 27, 2009196-day reviewClass II21 CFR 886.4390

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Od-Os GmbH · HQF Laser, Ophthalmic

Cleared on Oct 27, 2009 as substantially equivalent to K072823 (Meridian AG, 2007) and 4 other predicates after a 196-day review. Its family tree reaches back 4 generations to 1989. 3 later devices descend from it.

Decided: Oct 27, 2009
Review: 196 days
Class: Class II
Product code: HQF
Recalls: None
Predicates: 5

Its longest line of descent runs back 4 generations to K894841 (1989). 31 ancestors in all, the oldest K812219 (1981). 3 later devices descend from it, 1 citing it directly.

By dateBy generation

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 backK043486 Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005
This deviceK091064 Navilas Laser SystemOd-Os GmbH · 2009
Descendant · cites it directly · 2 of its ownK141851 Navilas Laser SystemOd-Os GmbH · 2015
Descendant · 2 generations on · 1 of its ownK162191 NAVILAS Laser SystemOd-Os GmbH · 2016
Descendant · 3 generations on · 0 of its ownK251772 Navilas Laser System 577sl (156691)Od-Os GmbH · 2025

Most influential descendants

Showing 3 of 3 · See all

K141851Navilas Laser SystemOd-Os GmbH · 2015 · cites it directly2descendants
K162191NAVILAS Laser SystemOd-Os GmbH · 2016 · 2 generations on1descendant
K251772Navilas Laser System 577sl (156691)Od-Os GmbH · 2025 · 3 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	K043486	Pascal Photocoagulator, Product-Pascal-01	Topcon Medical Laser Systems, Inc.	2005	—
0 (this device)	K091064	Navilas Laser System	Od-Os GmbH	2009	—
+1	K141851	Navilas Laser System	Od-Os GmbH	2015	—
+2	K162191	NAVILAS Laser System	Od-Os GmbH	2016	—
+3	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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2016	1	0
2025	1	0

FIG. 1 — Lineage of K091064, 1989–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 HQF? 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 HQF device

#1 K251772 Navilas Laser System 577sl (156691)score 13.6 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (5)

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	Applicant	Decided	Recalls
*	K072823	Merilas 532A Summary page 2 …TABLE 1 PREDICATE DEVICES FOR THE NAVILAS LASER SYSTEM 510(K)# TRDNAMI ANUFACTURER. K072823 MERILAS 532nm Laser Meridian AG K043486 Pascal Photocoagulator…	Meridian AG	2007	—
*	K043486	Pascal Photocoagulator, Product-Pascal-01 Summary page 2 …510(K)# TRDNAMI ANUFACTURER. K072823 MERILAS 532nm Laser Meridian AG K043486 Pascal Photocoagulator Optimedica Corporation K053044 OPTO Global Digital Fundus…	Topcon Medical Laser Systems, Inc.	2005	—
*	K053044	Opto Global Digital Fundus Camera System Model Ads 1.5 Summary page 2 …K072823 MERILAS 532nm Laser Meridian AG K043486 Pascal Photocoagulator Optimedica Corporation K053044 OPTO Global Digital Fundus OPTO Global, Inc. Camera System K05226…	Opto Global, Inc.	2006	—
*	K052268	Visucam Pro NM Summary page 2 …Optimedica Corporation K053044 OPTO Global Digital Fundus OPTO Global, Inc. Camera System K052268 VISUCAM PR NM Digital Camera Carl Zeiss Meditec AG K011877 FF450 Plus VISUPAC System…	Carl Zeiss Meditec, AG	2005	—
*	K011877	FF450 Plus Fundus Camera and Visupac Digital Image Archiving System, or FF450 Plus… Summary page 2 …OPTO Global, Inc. Camera System K052268 VISUCAM PR NM Digital Camera Carl Zeiss Meditec AG K011877 FF450 Plus VISUPAC System Carl Zeiss Jena GmbH DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICA…	Carl Zeiss Jena GmbH	2001	—

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K141851	Navilas Laser System	Od-Os GmbH	2015	2

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 20 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
1 of the 31 ancestors has a recall of any class.
Of its descendants, K141851 (Od-Os GmbH, 2015) has gone furthest, with 2 descendants of its own.

How does its category compare?

All HQF devices

HQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · HQF

3in 2025

2007high 7 (2009) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQF

264in 2025

2007high 295 (2015) · low 28 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HQF

1in 2025

2007high 5 (2011) · low 0 (2015)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HQF

106in 2025

2007high 111 (2022) · low 26 (2011)2025

MAUDE reports naming product code HQF, 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	4	198	2	60
2008	3	28	1	34
2009	7	115	2	33
2010	2	—	3	43
2011	4	128	5	26
2012	5	179	1	41
2013	6	225	2	39
2014	3	215	4	58
2015	4	295	0	80
2016	3	271	0	108
2017	3	189	0	77
2018	1	—	0	82
2019	4	107	0	66
2020	4	53	0	72
2021	1	—	0	100
2022	7	86	0	111
2023	5	155	0	92
2024	3	167	0	75
2025	3	264	1	106
2026	2	—	0	—

What is it indicated for?

The NAVILAS Laser System is a retinal photocoagulator integrated with a digital fundus camera. The NAVILAS is indicated for use in retinal photocoagulation, as well as for the imaging (capture, display, storage and manipulation) of the retina of the eye, including via color, fluorescein angiography and infra-red imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segments of the eye.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091064 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091064: Navilas Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091064

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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