Subjects: FDA, IMA
LASEROPTEK Co., Ltd.'s HELIOS IV-785tm Combination Picosecond 785nm + Nanosecond Nd:YAG Laser Receives FDA 510(k) Clearance for Use in Dermatology and General and Plastic Surgery
This Novel Aesthetic Medical Laser Merges the Power & Treatment Flexibility of a Nanosecond Q-Switch Laser with the Safety, Efficacy & Elegance of a High Energy & Stable 785nm Picosecond Laser into A Single Medical Aesthetic Laser System.
SEOUL, Republic of Korea, Sept. 1, 2022 /PRNewswire/ -- LASEROPTEK Co., Ltd., a developer, and manufacturer of world-class laser devices for aesthetic and medical dermatology applications, is pleased to announce its HELIOS IV-785 laser system recently received U.S. Food and Drug Administration 510(k) clearance for use in Dermatology and General and Plastic Surgery.
HELIOS IV-785's novel and synergistic combination of 785nm picosecond photoacoustic effect and 1064 & 532nm nanosecond thermal effect enables clinicians worldwide the flexibility and capability to effectively & non-ablatively treat a broad range of medical aesthetic indications across a wide range of Fitzpatrick Skin Types.
Skin toning & 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, offering clinicians safe and effective treatment flexibility.
As with all LASEROPTEK lasers, HELIOS IV-785 exhibits industry-leading pulse duration and energy stability born of LASEROPTEK's years of experience designing and building laser systems for medical and aesthetic dermatology. From the laser cavity to the power supply and delivery optics, LASEROPTEK lasers are developed in-house and from the ground up ensuring efficiency, stability, and 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," commented CJ Lee, President, and CEO.
"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," added Mr. Lee.
To learn more about HELIOS IV-785 and the entire suite of LASEROPTEK aesthetic and medical dermatology laser systems, please visit www.laseroptek.com.
LASEROPTEK is a global technology-driven medical device company in the aesthetic and medical laser space. Founded in 2000 and with in-house R&D capabilities, LASEROPTEK introduces safe, stable, and high-quality laser systems merging advanced laser technology with clinical efficacy.
Media Contacts:
Helena Lee
+82.31.8023.5150
Christopher Dalton
+1(619) 997-7905
SOURCE LASEROPTEK Co. Ltd.
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