# K180654: PINXEL-RF system

- Pathway: 510(k) (Traditional)
- Applicant: Rohrer Aesthetics, LLC
- Decided: Jul 13, 2018 after 122 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: 20 generations back to K943450 (1995). 282 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 286 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170325: Secret RF, Ilooda Co,., Ltd. (2017) Summary page 4.

## Most influential descendants
- K233099: Gladiator (2024), 0 descendants of its own
- K233143: PiXel8-Reveal (2024), 0 descendants of its own
- K233147: PiXel8-RF (2023), 0 descendants of its own

## Indications for use
The PINXEL-RF system is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Source page: https://510kreport.com/device/K180654
Methodology: https://510kreport.com/methodology