LASEROPTEK Co., Ltd. Receives FDA 510(k) Clearance for its Next Generation PicoLO Premium™ Picosecond Nd:YAG Laser
PicoLO Premium™’s FDA clearance comes on the heels of its February 2021 CE marking, and currently sells in Asia and Europe with its U.S. market debut slated for early 2022.
This second-generation true picosecond laser integrates new technologies to effectively address wrinkles, pigmented lesions, acne scars, and tattoo removal.
With this timely FDA clearance, we expect PicoLO Premium™ to play a major role in LASEROPTEK’s 2022 U.S. expansion by providing clinicians and patients with multiple clinical benefits.”
SEOUL, SOUTH KOREA, December 17, 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 recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its PicoLO Premium™ picosecond pulse Nd:YAG laser. — CJ Lee, CEO and President of LASEROPTEK
This clearance includes high-demand treatments for skin rejuvenation, acne scars, benign pigmented lesion elimination, and multi-color tattoo removal across a wide range of Fitzpatrick Skin Types.
PicoLO Premium represents a significant enhancement to LASEROPTEK’s first-generation PicoLO™ picosecond pulse Nd:YAG laser which received its initial FDA 510(k) clearance in early 2019. This next-generation aesthetic pico laser features a range of newly developed, novel handpieces showcasing LASEROPTEK’s in-house technical research and development capabilities synergistically combined with its grasp of laser-induced tissue reaction.
The Dia FX 1064 and 1064 S (Dual Intensive Application) handpieces provide clinicians the unique capability to selectively generate powerful 1064nm Laser Induced Optical Breakdown (LIOB) in the dermis, upper dermis, and epidermis via a simple and integral depth selection ring. Photoacoustic creation of LIOB is a capability unique to only highly stable picosecond lasers, erasing pigmentation and catalyzing collagen induction by generating micro-injuries in skin tissue, stimulating the body’s dynamic wound healing process. The Dia FX 1064 handpiece delivers a 10mm² DOE Fx flattop spot perfect for treating larger areas, and the novel Dia FX 1064 S type features a unique, 5mm² Fx flattop spot ideal for safely and effectively treating fine lines and wrinkles located in more delicate areas such as around the eyes and mouth.
Notably distinct, the Dia FX 532 handpiece is a powerhouse, producing Fx 532nm LIOB energy into the mid dermis enabling comfortable and impressive skin rejuvenation and pigment removal in skin types I-IV.
Ancillary handpieces include a 1064/532nm 10mm spot size collimator, the S20, a 20mm² collimated handpiece for quickly treating large surface areas; and a 1064/532nm 2-7mm Zoom handpiece designed for highly precise benign pigmented lesion and multi-color tattoo removal.
PicoLO Premium’s FDA clearance comes on the heels of its February 2021 CE marking, and currently sells in Asia and Europe with its U.S. market debut slated for early 2022. Mr. CJ Lee, President and CEO, expresses optimism in PicoLO Premium’s positive effect on the strong U.S. aesthetics market by commenting, “with this timely FDA clearance, we expect PicoLO Premium to play a major role in LASEROPTEK’s 2022 U.S. expansion by providing clinicians and patients with multiple clinical benefits only available from a potent and stable Nd:YAG picosecond pulse laser. PicoLO Premium’s market-leading pulse width and output energy stability consistently and selectively deliver photoacoustic LIOB in tissue. The result is dependable skin rejuvenation, effective acne scar and pigmentary lesion treatments as well as superb tattoo removal, at a value-based price point.”
“PicoLO Premium furnishes dermatology clinics, plastic surgery practices and Medical Spas with safe, efficacious and easy-to-perform treatments, effectively addressing the increasing demand for advanced, non-invasive and low to no downtime skin treatments for both on and off-the-face,” added Mr. Lee.
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:
Christopher Dalton
Vice President
+1 (619) 609-4757
dalton.christopher@laseroptek.com
Helena Lee
Marketing Director
+82 2-2135-1990
jylee@laseroptek.com
Visit us on social media @laseroptekco:
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Kyung Lee
LASEROPTEK Co., Ltd.
+82 10-7102-1178
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