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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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: K261217 (AnyPlus II Spinal Fixation System), K254302 (ECG Analysis Software (AiTiALVSD)), K260250 (QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)), K243223 (Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)).

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