WONTECH has announced that its picosecond laser device, PICOCARE, received U.S. Food and Drug Administration 510(k) clearance for tattoo removal. PICOCARE, licensed by the FDA, is a Picosecond Nd:YAG based laser, and is able to remove tattoos in various colors with fewer times with 1064nm, 532nm, 595nm, and 660nm multi-wavelength and selectively removes pigment particles to minimise damage to skin tissue.
Picosecond laser is a picosecond-level laser whose pulse duration is shorter than 1 nanosecond. It is more effective for treating pigmented lesions such as tattoos than nanosecond lasers.
With PICOCARE, WONTECH has been able to receive CE MDD of Europe and KFDA of Korea MFDS (Ministry of Food and Drug Safety), and now, it has received FDA clearance, stimulating the necessary momentum to expand the market worldwide.
Reno Kim, CEO of WONTECH said, "PICOCARE has received a lot of praise for successfully competing with the products of dominant global brands in the Korean market, which possesses strong interest and demand for lasers".
"Currently, it has emerged as one of the most popular kinds of picosecond laser equipment in Korea. As the performance and stability have already been verified through many procedures since its launch in Korea, we are looking forward to seeing rapid market penetration in the U.S. market as well."
In addition, WONTECH, which has attained numerous licenses and has increased its market share outside the U.S., has recently been conducting the FDA clearance with many products. As a result, WONTECH is well-positioned to emerge as a dark horse in the U.S. market.
In addition to PICOCARE, other products with FDA clearance include Pastelle, which is a Q-switched Nd:YAG laser, and Cosjet SR, which is a long pulsed Nd:YAG laser.