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Topcon’s Pascal Synthesis TwinStar receives 510(k) clearance

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The FDA has issued 510(k) clearance for the Pascal Synthesis TwinStar laser photocoagulator from Topcon, according to a company press release.

The device can treat retinal disorders with a 577 nm yellow wavelength or a 638 nm red wavelength. The yellow module allows treatment of a single spot as well as with a variety of patterns and four spot sizes, while the red wavelength is for single spot treatments with two spot sizes, the release said.

“Within ophthalmology, medical laser technology evolves at a rapid pace. Accordingly, offering users a variety of therapeutic modalities is critical,” Robert Gibson, vice president of eye care global marketing at Topcon, said in the release. “The addition of the TwinStar to Topcon’s product portfolio offers ophthalmologists an even wider range of treatment options for significant ocular conditions, including retinal disorders.”