# K212331: BodySculp

- Pathway: 510(k) (Traditional)
- Applicant: Rohrer Aesthetics, LLC
- Decided: Nov 9, 2021 after 105 days
- Product code: PKT (Laser For Disruption Of Adipocyte Cells For Aesthetic Use)
- Device class: 2
- Regulation: 21 CFR 878.5400
- 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). 184 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 186 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191068: Powersculp laser lipolysis system, Wuhan Lotuxs Technology Co., Ltd. (2019) Summary page 4.

## Most influential descendants
- K233099: Gladiator (2024), 0 descendants of its own

## Indications for use
The Bodysculp laser lipolysis system is intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.

Source page: https://510kreport.com/device/K212331
Methodology: https://510kreport.com/methodology