Laseroptek Co., Ltd., a developer, and manufacturer of laser devices for aesthetic and medical dermatology applications, announces that the U.S. FDA has granted 510(k) clearance to the Helios IV-785 laser system for use in dermatology and general plastic surgery.

Helios IV-785’s combination of 785nm picosecond photoacoustic effect and 1064 & 532nm nanosecond thermal effect enables clinicians to nonablatively treat a broad range of medical aesthetic indications across a wide range of Fitzpatrick Skin Types. Skin toning and brightening; benign pigmented and vascular lesion removal; and multi-color tattoo eradication, including blue and green inks, are all addressed by the combination of wavelengths and pulse durations provided by Helios OS IV-785. 

Moreover, from the laser cavity to the power supply and delivery optics, Laseroptek lasers are developed in-house and from the ground up, facilitating high performance over the lifetime of the laser. 

“Helios IV-785 represents Laseroptek’s dedication to continually develop, manufacture, and deliver technologically advanced lasers for medical and aesthetic dermatology,” says the CJ Lee, the company’s president and CEO.

“We are experiencing strong demand growth for this novel laser since its initial launch earlier this year in Korea,” he adds. “The U.S. 510(k) clearance paves the way for further expansion into more global markets, providing our distribution partners and their clinical customers a new, innovative laser system with a strong value proposition.”