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yandr system voluderm handpiece voluderm tips
Pollogen
Summary: The Yandr System Voluderm Handpiece by Pollogen is a medical device used for minimally invasive dermatological treatments. It is primarily used by dermatologists and cosmetic surgeons for skin rejuvenation and treatment of various skin conditions.
FDA Clearance Information
Pathway
510K
Number
K220124 ↗
Decision Date
February 17, 2022
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
The Yandr System Voluderm Handpiece, manufactured by Pollogen, received FDA clearance through the 510(k) pathway on February 17, 2022. It is classified as a Class 2 medical device under product code GEI.
What It Is
The Yandr System Voluderm Handpiece is a device designed for dermatological procedures, utilizing micro-needling technology combined with radiofrequency energy to promote skin rejuvenation. It works by creating controlled micro-injuries in the skin, stimulating collagen production and enhancing skin texture and appearance. This device is typically used in aesthetic medicine to address signs of aging, such as wrinkles and fine lines.
Clinical Applications
Commonly used in dermatology and cosmetic surgery, the Yandr System Voluderm Handpiece is employed in procedures aimed at improving skin texture, reducing wrinkles, and treating acne scars. It is suitable for use in outpatient settings, med spas, and dermatology clinics. The device is often used on adult patients seeking non-surgical skin rejuvenation options.
Indications for Use
The FDA-cleared indications for the Yandr System Voluderm Handpiece include its use in treating skin conditions that benefit from enhanced collagen production and skin texture improvement. It is particularly indicated for patients looking to reduce the appearance of wrinkles and improve overall skin quality.
Practical Considerations
The device features interchangeable tips for different treatment areas and depths, allowing for customization based on patient needs. Clinicians should be trained in the technique to ensure optimal results and minimize discomfort. Compatibility with existing clinic equipment should be verified before use.
Frequently Asked Questions
What is the Yandr System Voluderm Handpiece used for?
It is used for minimally invasive skin rejuvenation treatments, targeting wrinkles, fine lines, and acne scars.
What specialties typically use this device?
Dermatologists and cosmetic surgeons commonly use this device in aesthetic medicine.
What are the FDA-cleared indications?
The device is indicated for enhancing skin texture and reducing wrinkles through collagen stimulation.
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.