LASEROPTEK Co., Ltd. Receives FDA 510(k) With Expanded Aesthetic Indications for its PicoLO™ Picosecond Nd:YAG Laser
PicoLO, a non-invasive laser skincare system, has received 510(k) clearance from the FDA allowing it to expand its capabilities in addressing and treating benign pigmented lesions, acne scars, and wrinkles.
Nd:YAG True Picosecond Pulse Laser With Expanded Indications for Treatment of Benign Pigmented Lesions, Acne Scars, and Wrinkles
PicoLO’s new 510(k) with expanded cosmetic indications opens the door for cost-effective, advanced picosecond pulse laser skin rejuvenation treatments.”
SEOUL, SOUTH KOREA, April 27, 2021 /EINPresswire.com/ -- LASEROPTEK Co., Ltd., a developer and manufacturer of world-class laser devices for aesthetic and medical dermatology applications, is pleased to announce it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) expanding the indications for its PicoLO™ picosecond pulse Nd:YAG laser to include treatment of benign pigmented lesions, acne scars, and wrinkles. — Dr. William Philip Werschler, Spokane Dermatology and Werschler Aesthetics
This 510(k) clearance represents a significant milestone in PicoLO’s evolution as a world-class picosecond pulse Nd:YAG laser delivering powerful and consistent photoacoustic generated Laser Induced Optical Breakdown (LIOB) within the skin to quickly and effectively fracture and finely fragment artificial and natural pigments such as in tattoos and benign pigmented lesions. PicoLO’s unique handpiece technology coupled with industry-leading energy and pulse duration stability provides clinicians the capability to selectively deliver LIOB to the dermis, upper dermis, and epidermis as desired. This LIOB depth control enables targeted micro wounding; catalyzing the body’s wound healing response consequently facilitating neocollagenesis and neoelastinogenesis that safely and effectively reduces the appearance of scars and wrinkles.
LASEROPTEK’s President and CEO, CJ Lee, stated “The newly FDA-cleared indications for benign pigmented lesions, acne scars and wrinkles, added to PicoLO’s current indication for tattoo removal, marks PicoLO’s substantial progress in creating new opportunities for U.S. clinicians to deliver a wide range of safe, comfortable, and efficacious cosmetic laser procedures. This represents a further testament to our commitment to advance the development of laser-based energy devices bringing value to dermatologists, plastic surgeons, medical aesthetic practitioners, and their patients on a global basis,” added Mr. Lee.
Dr. William Philip Werschler, MD, FAAD, commented “PicoLO’s new 510(k) with expanded cosmetic indications opens the door for cost-effective, advanced picosecond pulse laser skin rejuvenation treatments. We are excited to work with LASEROPTEK to offer PicoLO procedures to our patients at Spokane Dermatology and Werschler Aesthetics.”
To learn more about PicoLO and the entire suite of LASEROPTEK aesthetic and medical dermatology laser systems, please contact Jayson Jonsson of Gale Force Aesthetics, LLC at +1(925) 705-6206 or visit www.laseroptek.com.
About LASEROPTEK Co., Ltd.
LASEROPTEK is a global, technology-driven medical device company with a focus on aesthetic and medical lasers. Founded in 2000 and with in-house R&D capabilities, LASEROPTEK develops, manufactures, and markets safe, stable, and high-quality laser systems merging advanced laser technology with clinical efficacy.
Media Contacts:
Helena Lee
Marketing Director
+82 2-2135-1990
jylee@laseroptek.com
Christopher Dalton
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+1 (619) 609-4757
dalton.christopher@laseroptek.com
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