| K-number | K252888 |
| Device name | NeoSculpt Plus |
| Applicant | S&M Medical Co., Ltd. |
| Product code | PBX |
| Device class | Class II |
| Decision date | Mar 9, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 878.4400 |
The NeoSculpt Plus is a radiofrequency (RF) therapeutic device that delivers electrical energy through handpieces to elevate tissue temperature for treating pain, muscle spasms, and improving local circulation. It comprises a main console, RF handpieces (handheld or handsfree modes), and neutral electrodes that attach to the patient's skin.
The device operates at 1 MHz and 2 MHz output frequencies with monopolar RF type, temperature sensors, and impedance monitoring. It has lower maximum power output (260 W vs. 300 W) and voltage (200 Vrms vs. 250 Vrms) than the predicate truSculpt iD, with slightly different physical dimensions and weight. Both devices use identical handpiece configurations (16 cm² and 40 cm² options) and conductive split-plate neutral electrodes.
Testing followed AAMI ANSI ES60601-1:2005+AMD1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2010+AMD1:2013, IEC 60601-2-2:2017 for electrical safety and EMC; ANSI AAMI IEC 62304:2006 and IEC 62366 for software validation; and EN ISO 14971:2007 for risk management.
The NeoSculpt Plus shares the same basic design components, operating principles, and user interface as the predicate truSculpt iD. Despite lower power and voltage outputs, comprehensive bench testing confirmed the device maintains target skin temperatures and achieves the same therapeutic effects without safety concerns. The differences in physical specifications and performance do not raise new safety or effectiveness questions.
View the full FDA submission: accessdata.fda.gov