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Navilas® Laser System 577sl

OD-OS GmbH · Model Navilas® Laser System 577sl · UDI-DI 04260284390082

HQF Prescription

510(k) clearances

1,534

Adverse events

Recalls

Facilities

Description

The Navilas® Laser System 577sl is a laser photocoagulator with an integrated digital fundus camera. The Navilas® Laser System 577sl combines imaging technologies (fundus live imaging, and infra-red imaging) with established laser photocoagulation treatment methods by providing the doctor a system for imaging and treatment planning prior to the photocoagulation.

Recalls

Date	Firm	Reason
2025-12-05	Beaver-Visitec International, Inc.	Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. Th
2023-03-16	Ellex Medical Pty Ltd.	When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output
2021-04-14	Dutch Ophthalmic USA, Inc.	Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01
2016-07-15	Topcon Medical Laser Systems, Inc	Topcon discovered an anomaly with titration, only when EpM is turned on during the titration process. This event may occur if the user turns on EpM, turns off the Landmark (LM) fu
2016-02-01	Laserex Systems Inc.	The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented.
2014-12-18	Ziemer Usa Inc	The devices were not shipped with the Starter Kits.
2014-11-04	Bausch & Lomb Inc	A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
2014-11-04	Bausch & Lomb Inc	A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
2014-11-04	Bausch & Lomb Inc	A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
2014-08-15	Lumenis, Inc.	Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.