By Kyeongmin Bae | JoongAng Ilbo | Published April 9, 2026
LSSA(NP-200)
Ultrasound medical device company Newpong has announced FDA 510(k) clearance (K252495) for its ultrasonic fat-dissolution system, LSSA (NP-200).
LSSA uses ultrasound energy to break down and emulsify subcutaneous fat, enabling effective body contouring while minimizing tissue damage during liposuction. The device is classified as Class II under 21 CFR 878.5040 and is cleared for use in plastic and orthopedic surgery.
The clearance represents external validation of Newpong's surgical ultrasound technology against one of the world's most rigorous regulatory standards. With FDA clearance now secured in addition to its existing ANVISA certification in Brazil, LSSA holds regulatory approval across both North and South America, covering two of the most significant markets for aesthetic and surgical medical devices globally.
The Americas represent a core region for global demand for aesthetic and surgical devices, and the clearance is expected to meaningfully expand Newpong's commercial prospects in those markets. The company plans to accelerate global partnership development and distribution network buildout on the back of this milestone, with a phased strategy centered on the U.S. market before expanding into additional key countries.
"This FDA clearance is an important milestone for entering global markets," said a Newpong representative. "We plan to focus on expanding our international presence and generating commercial results on this foundation."
