Voyager DSLT (430840610)

The Voyager DSLT is a Q-switched, 532 nm Nd:YAG laser designed for selective laser trabeculoplasty (SLT), a procedure to treat glaucoma. It delivers 120 laser spots in a predefined elliptical pattern to the trabecular meshwork through the limbus without requiring a contact lens, using automated targeting with eye-tracking compensation for patient movement.

The Voyager DSLT is identical to its predicate device (BELKIN Eagle) in laser type, wavelength (532 nm), pulse duration (3 ns), pulse energy range (1.1–1.9 mJ), repetition rate (50 Hz), spot diameter (400 µm), aiming laser (635 nm diode), delivery method (automated non-contact pattern delivery), and physical dimensions. Software was updated with three features: completion of interrupted treatments, target definition screen modifications, and automated test card results export—none raising new safety or effectiveness questions.

IEC 62304:2015 Medical Device Software - Software Life Cycle Processes; FDA 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' (major level of concern); FDA 'Applying Human Factors and Usability Engineering to Medical Devices' guidance.

The Voyager DSLT has identical indications for use, laser parameters, target tissue, delivery method, and auxiliary optical characteristics as the predicate Eagle device. The three software changes do not introduce new safety or effectiveness questions and are supported by bench testing, human factors analysis, and validation testing. Non-clinical testing demonstrates the device functions as intended and is substantially equivalent to the predicate device.