# K023111: Gyrus Plasma Skin Resurfacing System

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Medical, Inc.
- Decided: Mar 13, 2003 after 175 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: 9 generations back to K943450 (1995). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992180: Visage Cosmetic Surgery, Model V5000, Arthrocare Corp. (2000) Summary page 1.
- K013639: Thermage Thermacool TC System, Thermage, Inc. (2002)
- K974789: Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L, Lumenis, Inc. (1998)

## Indications for use
The Gyrus Medical PSR System is intended for treatment of the following dermatological conditions: Superficial skin lesions Actinic Keratosis Viral papillomata Sceborrhoeic Keratosis

Source page: https://510kreport.com/device/K023111
Methodology: https://510kreport.com/methodology