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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 procedures, primarily by dermatologists and plastic surgeons. It is designed to treat various skin conditions by ablating the skin surface with plasma energy.
FDA Clearance Information
Pathway
510K
Number
K041999 ↗
Decision Date
March 2, 2005
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 2, 2005. Manufactured by Gyrus Medical, it is classified as a Class II device under product code GEI.
What It Is
The Gyrus Plasma Skin Resurfacing System is a device that uses plasma energy to ablate the skin's surface, promoting regeneration and improving skin texture and appearance. It operates by ionizing gas to create plasma, which delivers controlled thermal energy to the skin. This process helps in reducing wrinkles, scars, and other skin irregularities.
Clinical Applications
This device is commonly used in dermatology and plastic surgery settings for procedures such as wrinkle reduction, scar revision, and treatment of sun-damaged skin. It is suitable for outpatient settings and is often used on patients seeking cosmetic improvements in skin texture and tone. The device is particularly beneficial for patients with superficial skin lesions or those requiring non-invasive skin rejuvenation.
Indications for Use
The FDA-cleared indications for this device include skin resurfacing and treatment of dermatological conditions that benefit from controlled ablation. It is intended for patients with conditions like acne scars, fine lines, and other superficial skin imperfections.
Practical Considerations
Clinicians should consider the skin type and condition of the patient when selecting this device for treatment. Proper training in the use of plasma technology is essential to optimize results and minimize risks. The device is compatible with standard dermatological practice settings and requires adherence to safety protocols to prevent complications.
Frequently Asked Questions
What is the Gyrus Plasma Skin Resurfacing System used for?
It is used for skin resurfacing procedures to improve skin texture and appearance by ablating the skin surface with plasma energy.
What specialties typically use this device?
Dermatologists and plastic surgeons commonly use this device for cosmetic skin treatments.
What are the FDA-cleared indications?
The device is cleared for skin resurfacing and treating conditions like acne scars and fine lines through controlled ablation.
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.