# K252888: NeoSculpt Plus

- Pathway: 510(k) (Traditional)
- Applicant: S&M Medical Co., Ltd.
- Decided: Mar 9, 2026 after 180 days
- Product code: PBX (Massager, Vacuum, Radio Frequency Induced Heat)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K943450 (1995). 113 ancestors in all.
No later device cites it as a predicate yet.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223110: truSculpt iD, Cutera, Inc. (2022) Summary page 6.

## Indications for use
The NeoSculpt Plus is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as relief of pain and muscle spasms and increase in local circulation.

Source page: https://510kreport.com/device/K252888
Methodology: https://510kreport.com/methodology