# K981870: Visage Cosmetic Surgery System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: Aug 20, 1998 after 84 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: 5 generations back to K943450 (1995). 15 ancestors in all.
1,073 later devices descend from it; 4 cite it directly.
0 of 1,089 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964849: Arthrocare Dermatologic Electrosurgery System, Arthrocare Corp. (1997) Summary page 1.
- K963123: Arthrocare Arthroscopic Eletrosurgery System (Model 980), Arthrocare Corp. (1996) Summary page 1.
- K973478: Arthrocare Sinus Electrosurgery System, Arthrocare Corp. (1998) Summary page 1.
- K800617: Hyfrecator, #733, Birtcher Corp. (1980) Summary page 1.

## Most influential descendants
- K000944: Thermage Thermacool System (2000), 1,069 descendants of its own
- K013034: Modification to: Thermacool Iia (2001), 800 descendants of its own
- K013639: Thermage Thermacool TC System (2002), 799 descendants of its own
- K021402: Thermage Thermacool TC System (2002), 789 descendants of its own
- K030142: Thermacool TC System (2003), 773 descendants of its own

## Indications for use
The Visage Cosmetic Surgery System is a bipolar high frequency electrosurglcal device intended for general dermatologic surgery for soft tissue resection/removal, and hemostasis/coagulation in procedures using conductive solutions such as saline or Ringer’s Lactate as an irrigant.

Source page: https://510kreport.com/device/K981870
Methodology: https://510kreport.com/methodology