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gyrus plasma skin resurfacing system
Gyrus Medical
Summary: The Gyrus Plasma Skin Resurfacing System is a medical device used for skin resurfacing and ablation. It is typically used by dermatologists and plastic surgeons for cosmetic and therapeutic procedures.
FDA Clearance Information
Pathway
510K
Number
K023111 ↗
Decision Date
March 13, 2003
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
The Gyrus Plasma Skin Resurfacing System was cleared through the FDA 510(k) pathway on March 13, 2003, by Gyrus Medical. It is a Class 2 medical device under product code GEI.
What It Is
The Gyrus Plasma Skin Resurfacing System is a device that uses plasma energy to ablate and resurface the skin. It operates by delivering controlled plasma energy to the skin's surface, promoting collagen remodeling and improving skin texture. This technology is often used in cosmetic dermatology to treat wrinkles, scars, and other skin irregularities.
Clinical Applications
Clinically, this device is used in dermatology and plastic surgery settings for procedures such as wrinkle reduction, scar revision, and skin rejuvenation. It is suitable for patients seeking cosmetic improvements or therapeutic interventions for skin conditions. The device is typically used in outpatient settings, allowing for quick recovery and minimal downtime.
Indications for Use
The FDA-cleared indications for this device include skin resurfacing and ablation, which are beneficial for patients with wrinkles, scars, and other skin texture issues. It is designed for use in patients who require cosmetic or therapeutic skin treatments.
Practical Considerations
The device is available in various sizes to accommodate different treatment areas. It is compatible with standard dermatological and surgical equipment. Clinicians should be trained in plasma energy techniques to ensure optimal results and patient safety.
Frequently Asked Questions
What is the Gyrus Plasma Skin Resurfacing System used for?
It is used for skin resurfacing and ablation, improving skin texture and appearance.
What specialties typically use this device?
Dermatologists and plastic surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for skin resurfacing and ablation, targeting wrinkles, scars, and skin irregularities.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.