# K231092: T-Shape 2

- Pathway: 510(k) (Traditional)
- Applicant: B&M S.R.L. Marketing Nel Benessere
- Decided: Sep 22, 2023 after 157 days
- Product code: NUV (Massager, Vacuum, Light Induced Heating)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K943450 (1995). 118 ancestors in all.
No later device cites it as a predicate yet.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122579: Velashape, Syneron Medical, Ltd. (2012) Summary page 4.
- K191528: Venus Legacy Pro Device, Venus Concept USA, Inc. (2019) Summary page 4.
- K211272: ICOONE Laser Med (also referred to as ICOONE Medical laser), I-Tech Industries Srl (2021) Summary page 4.

## Indications for use
The T-SHAPE 2 and its hand pieces are indicated for the relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K231092
Methodology: https://510kreport.com/methodology