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FDA issues 510(k) clearance for Topcon’s Pascal Synthesis laser

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Topcon Medical Laser Systems has received 510(k) clearance from the U.S. Food and Drug Administration for its portable, dual-port, pattern-scanning laser, the Pascal Synthesis, according to a news release.

The device, which is available in 532-nm and 577-nm wavelengths, can be integrated with both Topcon D7 and Haag-Streit-style slit lamps.

The combination will allow physicians the opportunity to use pattern-scanning laser technology to treat retinal disorders such as diabetic retinopathy, age-related macular degeneration and retinal vascular occlusive disease using a slit lamp set up.

Topcon also offers Endpoint Management as an upgrade on the Synthesis lasers, which is intended to provide increased precision, efficiency and control, according to the release.