đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use in dermatologic procedures involving controlled microneedling and radiofrequency energy delivery.
- Treatment intended to improve the appearance of facial wrinkles and skin texture.
- Treatment intended to improve the appearance of acne scars.
Clinical Applications
- Minimally invasive radiofrequency microneedling treatments of the skin.
- Treatment of facial wrinkles and fine lines.
- Improvement of uneven or degraded skin texture.
- Treatment of acne-scar appearance.
- Outpatient dermatology or cosmetic procedures in appropriately selected adult patients.
Practical Considerations
- The system uses interchangeable Voluderm tips, which may allow clinicians to select different treatment areas or needle depths according to the device labeling and treatment plan.
- Treatment should be performed by clinicians trained in radiofrequency microneedling technique, patient selection, skin preparation, and management of expected skin reactions.
- The device is intended for use with compatible system components; facilities should verify handpiece, tip, generator, and accessory compatibility before treatment.
- Contraindications and precautions depend on the complete manufacturer labeling and patient assessment, including active skin infection, impaired wound healing, and conditions or medications that increase bleeding or infection risk.
- This is an external dermatology device rather than an implanted device. MRI safety should be confirmed from the current manufacturer instructions; do not assume the handpiece or tips are safe in the MRI environment.
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.