FDA Clears LASEROPTEK's HELIOS IV-785 for Aesthetic and Medical Dermatology Use

HELIOS IV-785's novel and synergistic combination of 785nm picosecond photoacoustic effect and 1064 & 532nm nanosecond thermal effect.

The U.S. Food and Drug Administration has granted 510(k) clearance to LASEROPTEK Co., Ltd.’s HELIOS IV-785 laser system for aesthetic and medical dermatology applications.

HELIOS IV-785's novel and synergistic combination of 785nm picosecond photoacoustic effect and 1064 & 532nm nanosecond thermal effect provides flexibility and capability to effectively and non-ablatively treat a broad range of medical aesthetic indications across a wide range of Fitzpatrick Skin Types. 

Skin toning and brightening; benign pigmented & vascular lesion removal, and multi-color tattoo eradication, including blue and green inks, are all effectively addressed by the novel combination of wavelengths and pulse durations provided by HELIOS IV-785. The natively generated and high energy, 600 picosecond pulse duration 785nm wavelength fills the void between traditional Nd:YAG 532nm & 1064nm wavelengths.

"HELIOS IV-785 represents LASEROPTEK's dedication to continually develop, manufacture, and deliver technologically advanced lasers for medical and aesthetic dermatology," says CJ Lee, LASEROPTEK's President, and CEO, in a news release. 

"We are experiencing strong demand growth for this novel laser since its initial launch earlier this year in Korea. 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," says Mr. Lee.