Newpong Demonstrates Global Ultrasound Expertise with FDA 510(k) Clearance for ‘LSSA’

Newpong announced that it has obtained U.S. FDA 510(k) clearance (K252495) for 'LSSA (NP-200),' a minimally invasive ultrasonic liposuction medical device.

LSSA is a minimally invasive ultrasonic liposuction medical device equipped with an ultra-thin probe as small as 0.9 mm in diameter. It is designed to be applied to precise anatomical areas that were previously difficult to access with conventional equipment, such as the double chin, axillary fat, and calves. By supporting a range of ultra-thin probes from 0.9 mm to 3.7 mm within a single system, it is capable of handling everything from delicate procedures on small areas to large-volume fat removal.

The core technology of the device is the 'Deep Sono Algorithm,' proprietary technology developed by Newpong. This technology detects frequencies in real-time during the procedure, maintaining a constant power output regardless of changes in tissue characteristics. By ensuring uniform energy delivery irrespective of variations in the density and moisture content of adipose tissue, it enhances both the safety and reproducibility of the procedure.

The FDA clearance is considered highly significant, as it marks international recognition of the company’s technological capabilities and clinical application experience by global standards.

In particular, with the addition of the FDA clearance to its existing Brazilian ANVISA certification, LSSA has established a robust regulatory foundation for entry into key global markets. Furthermore, the recent appointment of Dr. Osvaldo Saldanha, a renowned Brazilian plastic surgeon, as a global Key Opinion Leader (KOL) for LSSA is further strengthening its clinical foundation and global references.

A representative from Newpong stated, 'This FDA clearance holds the significance of technical validation,' adding, 'Building on this foundation, we plan to further strengthen our technological competitiveness in the global market.