Topcon PASCAL Synthesis laser gets 510(k) clearance

Santa Clara, CA-Topcon Medical Laser Systems has received FDA 510(k) clearance for its portable, dual-port, pattern-scanning laser (PASCAL Synthesis).

Available in either 532- or 577-nm wavelengths, the device will allow fast and effective treatment of retinal disorders using clinically proven PASCAL technology, while offering physicians the option of keeping their current slit lamp set-up, the company said in a prepared statement. The laser is designed to integrate with Topcon D7 and Haag-Streit style-slit lamps.

“The introduction of the PASCAL Synthesis will, for the first time, offer physicians a more cost-effective solution in providing their patients pattern-scanning laser technology,” said Tom Koike, president and chief executive officer at Topcon. “And with Endpoint Management available as an upgrade on all Synthesis lasers, physicians will have the option to treat at sub-threshold levels for less-damaging treatment of a variety of retinal diseases.”

The marriage of these two technologies allows for greater control, efficiency, and precision, resulting in positive therapeutic outcomes at non-damaging treatment levels.

“It is an additional step toward offering customers new and improved technologies that not only complement their laser treatment portfolio, but provide greater clinical benefits for their patients,” Koike added.

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