# K020408: System 2000 Controller, System 5000 Controller, Footswitch, Power Cord, and Visage Wandsff

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: May 2, 2002 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: 3 generations back to K936109 (1994). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001302: Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000 Footswitch, Plasma Scalpel GS, C, Arthrocare Corp. (2000) Summary page 1.
- K003624: Refinity System, Refinity Handpiece and Cable, Refinity Footswitch, Refinity Power Cord, Model V5100-00,V5701-00,V5702, Arthrocare Corp. (2000) Summary page 1.
- K963339: Coherent Ultrapulse CO2 Surgical Lasers, Coherent Medical Group (1997) Summary page 1.
- K980177: Sugitron Model: Iec, Ellman Intl., Inc. (1998) Summary page 1.
- K981361: Powerstar Bipolar Scissors, ETHICON, Inc. (1998) Summary page 1.
- K991297: Uni-Laser 450P CO2 Laser System & Accessories, Medart Corp. (1999) Summary page 1.

## Indications for use
The Visage Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in general dermatology, cosmetic, plastic, and reconstructive surgery including: Abscesses; Oculoplastic Procedures; Aponeurotic Repair; Panniculectomy; Basal Cell Carcinoma; Papilloma Keloids; Biopsy; Pedicle Flap; Blepharoplasty; Rhytidectomy; Cosmetic Repairs; Development of Skin Flaps; Cysts; Skin Tags; Epithelioma; Skin Resurfacing for Treatment of Wrinkles, Rhytides, and Furrows; Keratosis; Mammaplasty; Nevi (Moles); Verrucae (Warts)

Source page: https://510kreport.com/device/K020408
Methodology: https://510kreport.com/methodology