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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / April 2026 / K252495

510(k) cleared

LSSA (NP-200)

Newpong Co., Ltd. · Apr 3, 2026 · K252495

FDA cleared the LSSA (NP-200) from Newpong Co., Ltd. on Apr 3, 2026 under K252495, a traditional 510(k). The device falls under product code QPB, System, Suction, Lipoplasty For Removal, regulated at 21 CFR 878.5040 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Aug 8, 2025. The decision came 238 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Newpong Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252495?

K252495 is the FDA 510(k) for LSSA (NP-200), submitted by Newpong Co., Ltd.. FDA's decision date was Apr 3, 2026, under product code QPB (System, Suction, Lipoplasty For Removal).

Who makes the LSSA (NP-200)?

Newpong Co., Ltd., based in Seoul, is the applicant of record for K252495.

How long did the K252495 review take?

FDA received the submission on Aug 8, 2025 and issued its decision on Apr 3, 2026, 238 days later.

← All decisions in April 2026