# K162191: NAVILAS Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Od-Os GmbH
- Decided: Nov 22, 2016 after 110 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: 11 generations back to K894841 (1989). 43 ancestors in all.
1 later device descends 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)
- K141851: Navilas Laser System, Od-Os GmbH (2015) Summary page 5.

## Most influential descendants
- K251772: Navilas Laser System 577sl (156691) (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K162191
Methodology: https://510kreport.com/methodology