# K141851: Navilas Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Od-Os GmbH
- Decided: Jan 2, 2015 after 177 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K894841 (1989). 42 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091064: Navilas Laser System, Od-Os GmbH (2009) Summary page 5.
- K123542: Pascal Synthesis (532NM/577NM) Opthalmic Laser, Topcon Medical Laser Systems, Inc. (2013) Summary page 5.
- K071687: Famili of Iridex IQ Laser Systems, Iridex Corp (2008) Summary page 5.
- K091581: Supra 577.Y Laser, Quantel Medical (2009) Summary page 5.

## Most influential descendants
- 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/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.

Source page: https://510kreport.com/device/K141851
Methodology: https://510kreport.com/methodology