# K082109: Bovie Icon General Purpose RF Generator

- Pathway: 510(k) (Traditional)
- Applicant: Bovie Medical
- Decided: Oct 2, 2008 after 69 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: 3 generations back to K932293 (1994). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022856: Bovie Ids-300 High Frequency Electrosurgical Generator, Aaron Medical Industries (2003) Summary page 1.
- K061884: Bovie Icon GI Electrosurgical Generator, Model GI 120, Bovie Medical (2006)
- K043273: Ligasure Vessel Sealing System. Ligasure Instruments, Valleylab (2005) Summary page 1.

## Most influential descendants
- K092383: Bovie Icon VS General Purpose RF Generator, Model: VS300 (2010), 0 descendants of its own

## Indications for use
The Bovie ICON GP Generator is used to deliver high frequency radiofrequency energy in conjunction with other surgical devices for electrosurgical cutting, coagulation, or vessel sealing.

Source page: https://510kreport.com/device/K082109
Methodology: https://510kreport.com/methodology