# K251772: Navilas Laser System 577sl (156691)

- Pathway: 510(k) (Traditional)
- Applicant: Od-Os GmbH
- Decided: Oct 29, 2025 after 141 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: 12 generations back to K894841 (1989). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223132: Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models), Iridex Corporation (2022) Summary page 5.
- K162191: NAVILAS Laser System, Od-Os GmbH (2016) Summary page 5.
- K170302: Yellow Laser Photocoagulator Ylc-500, Nidek Co., Ltd. (2017) Summary page 5.

## Indications for use
The Navilas® Laser System is an ophthalmic laser integrated with a digital camera. The Navilas® Laser System is indicated for the treatment of ocular pathology in the anterior and posterior segment of the eye, with supporting imaging functions (capture, display, storage and annotation) of the retina of the eye via color and infrared imaging. The Navilas® Laser System is intended for use in the posterior segment to perform Retinal Photocoagulation, Panretinal photocoagulation, focal photocoagulation or grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: • Proliferative and non-proliferative diabetic retinopathy • Macular edema • Choroidal neovascularization associated with wet age-related macular degeneration • Age-related macular degeneration • Central and branch retinal vein occlusion • Lattice degeneration • Retinal tears and detachments Intended for use in the treatment of ocular pathology in the anterior segment including: • Iridotomy • Iridoplasty • Trabeculoplasty

Source page: https://510kreport.com/device/K251772
Methodology: https://510kreport.com/methodology