# K041999: Gyrus Plasma Skin Resurfacing System

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Medical, Inc.
- Decided: Mar 2, 2005 after 219 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
No predicates in its family tree.
111 later devices descend from it; 1 cites it directly.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K023111: Gyrus Plasma Skin Resurfacing System, Gyrus Medical, Inc. (2003). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K060948: Portrait PSR3 (2006), 110 descendants of its own
- K071786: Portrait PSR (2007), 109 descendants of its own
- K072394: Portrait Stand-Off (2007), 104 descendants of its own
- K073572: Matrix RF Applicator (2008), 102 descendants of its own
- K101510: Fractional Skin Resurfacing (FSR) Applicator (2011), 64 descendants of its own

## Indications for use
The Gyms Medical PSR System is intended for treatment of the following dermatological conditions: * Rhytides of the face * Superficial skin lesions * Actinic Keratosis * Viral papillomata * Seborrhoeic Keratosis The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Source page: https://510kreport.com/device/K041999
Methodology: https://510kreport.com/methodology