# K233099: Gladiator

- Pathway: 510(k) (Traditional)
- Applicant: Rohrer Aesthetics, LLC
- Decided: May 22, 2024 after 239 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- 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: 23 generations back to K943450 (1995). 375 ancestors in all.
No later device cites it as a predicate yet.
0 of 376 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180654: PINXEL-RF system, Rohrer Aesthetics, LLC (2018) Summary page 4.
- K212331: BodySculp, Rohrer Aesthetics, LLC (2021) Summary page 4.
- K102524: Futura, Dr. Oliver Wenker, M.D., M.B.A. (2011) Summary page 4.

## Indications for use
The Gladiator system contains three handpieces, each of which has its own indications for use. The PiXel8-RF handpiece is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostatis. The Bodysculp laser lipolysis handpiece 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. The BodyTone handpiece is intended for Relaxation of muscle spasms, Prevention or retardation of disuse atrophy, Increasing local blood circulation, Muscle re-education, Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or increasing range of motion. Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

Source page: https://510kreport.com/device/K233099
Methodology: https://510kreport.com/methodology