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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 / March 2026 / K252888

510(k) cleared

NeoSculpt Plus

S&M Medical Co., Ltd. · Mar 9, 2026 · K252888

FDA cleared the NeoSculpt Plus from S&M Medical Co., Ltd. on Mar 9, 2026 under K252888, a traditional 510(k). The device falls under product code PBX, Massager, Vacuum, Radio Frequency Induced Heat, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 10, 2025. The decision came 180 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

S&M Medical Co., Ltd. has 8 other decisions in the tracker over the last 12 months: K253808 (AIR Recon DL), K253667 (Accoat Guide Wire), K254130 (C.A. Medical Interbody Fusion System), K253317 (Cytrans Elashield).

Questions & Answers

What did FDA clear under K252888?

K252888 is the FDA 510(k) for NeoSculpt Plus, submitted by S&M Medical Co., Ltd.. FDA's decision date was Mar 9, 2026, under product code PBX (Massager, Vacuum, Radio Frequency Induced Heat).

Who makes the NeoSculpt Plus?

S&M Medical Co., Ltd., based in Gwangju, is the applicant of record for K252888.

How long did the K252888 review take?

FDA received the submission on Sep 10, 2025 and issued its decision on Mar 9, 2026, 180 days later.

← All decisions in March 2026