Cynosure Gets FDA Approval To Market New PicoSure Energy Delivery System For Tattoos And Pigmented Lesions

Cynosure, Inc. CYNO said Tuesday it received Food and Drug Administration 510(k) approval to market a new Laser Delivery System for PicoSure, the world's first aesthetic picosecond laser. According to the company, it would broaden its product platform for tattoo removal and skin revitalization.

Cynosure said that along with the FDA cleared 532 nm and 755 nm wavelengths, its new 1064 nm Laser Delivery System enhances the multi-wavelength laser technology for removing the full color spectrum of tattoo inks in fewer treatments.

Commenting on the FDA approval, the company's CEO, Michael Davin, said, "PicoSure is widely recognized by aesthetic practitioners for its unsurpassed clinical efficacy and proven performance. Consumers simply know it works. With the FDA clearance of the 1064 nm Laser Delivery System we believe our picosecond technology has the broadest range of clearances on the market. The new 1064 nm wavelength builds on our aesthetic industry leadership and expands PicoSure's versatility for tattoos, pigmentation and skin revitalization."

According to Cynosure, the new 1064 nm wavelength is meant for removal of black and other dark tattoo inks. The company added that engineered to complement the highly versatile 755 nm wavelength, as well as, its proprietary FOCUS Lens Array, the 1064 nm and 532 nm Laser Delivery Systems improve PicoSure's ability to remove tattoos and treat a range of dermatologic conditions. That included wrinkles, acne scars and pigmented lesions.

The company also indicated that the 1064 nm wavelength would be offered as an upgrade to the current PicoSure customers. It added that the initial shipments of the new Laser Delivery System would likely commence in the second half of the current year.