# K091064: Navilas Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Od-Os GmbH
- Decided: Oct 27, 2009 after 196 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K894841 (1989). 31 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072823: Merilas 532A, Meridian AG (2007) Summary page 2.
- K043486: Pascal Photocoagulator, Product-Pascal-01, Topcon Medical Laser Systems, Inc. (2005) Summary page 2.
- K053044: Opto Global Digital Fundus Camera System Model Ads 1.5, Opto Global, Inc. (2006) Summary page 2.
- K052268: Visucam Pro NM, Carl Zeiss Meditec, AG (2005) Summary page 2.
- K011877: FF450 Plus Fundus Camera and Visupac Digital Image Archiving System, or FF450 Plus Visupac System, Carl Zeiss Jena GmbH (2001) Summary page 2.

## Most influential descendants
- K141851: Navilas Laser System (2015), 2 descendants of its own
- K162191: NAVILAS Laser System (2016), 1 descendant of its own
- K251772: Navilas Laser System 577sl (156691) (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K091064
Methodology: https://510kreport.com/methodology