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FDA 510(k)

NeoSculpt Plus

K-Number: K252888 · 2026-03-09

ApplicantS&M Medical Co., Ltd.
Decision Date2026-03-09
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NeoSculpt Plus is a medical device manufactured by S&M Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-03-09 under approval number K252888. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeoSculpt Plus?

NeoSculpt Plus is a medical device that received FDA 510(k) clearance on 2026-03-09. It is manufactured by S&M Medical Co., Ltd.. The 510(k) number is K252888.

When was NeoSculpt Plus approved by the FDA?

NeoSculpt Plus received FDA 510(k) clearance on 2026-03-09, under approval number K252888.

What company makes NeoSculpt Plus?

NeoSculpt Plus is manufactured by S&M Medical Co., Ltd..

What is the FDA product code for NeoSculpt Plus?

The FDA product code for NeoSculpt Plus is PBX.

Related Devices (Code: PBX)

K162512truSculptCutera, Inc. K161458Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep CareIndiba USA, Inc. K161551TR-100BTL Industries, Inc. K161043Profound SystemSyneron Candela Corporation K160329InMode System MiniFX HandpieceInmode MD , Ltd. K161199EndyMed Contour HandpieceEndymed Medical, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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