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fractional skin resurfacing fsr applicator
Endymed Medical
Summary: The fractional skin resurfacing FSR applicator by Endymed Medical is a device used for skin resurfacing and tightening, primarily by dermatologists and cosmetic surgeons. It is designed to treat conditions like acne scars and improve skin texture.
FDA Clearance Information
Pathway
510K
Number
K101510 ↗
Decision Date
February 17, 2011
Product Code
OUH
Device Class
Class 2
Evidence
0 studies
The fractional skin resurfacing FSR applicator, manufactured by Endymed Medical, received FDA clearance through the 510k pathway on February 17, 2011. It is classified as a Class 2 device under the product code OUH.
What It Is
The fractional skin resurfacing FSR applicator is a medical device that uses phase-controlled multi-source radiofrequency technology to perform skin resurfacing. It delivers microfractional resurfacing to the epidermis while providing volumetric heating to the dermis, promoting collagen remodeling. This dual-action approach aims to improve skin texture and reduce the appearance of scars with minimal downtime.
Clinical Applications
This device is commonly used in dermatology and cosmetic surgery settings for patients seeking treatment for acne scars, wrinkles, and skin laxity. It is particularly beneficial for patients looking for non-invasive options with minimal recovery time. The device is suitable for various skin types and can be used in outpatient settings.
Indications for Use
The FDA-cleared indications for this device include skin resurfacing and tightening, particularly for conditions like acne scars. It is intended for patients who require improvement in skin texture and appearance.
Practical Considerations
The device is typically compatible with standard dermatology and cosmetic surgery equipment. Clinicians should be trained in its use to optimize results and minimize risks. It is important to assess patient skin type and condition before treatment to ensure appropriate application.
Related Literature
The linked study evaluated the efficacy of the multisource fractional radiofrequency skin resurfacing applicator in treating acne scars. The study found that the device effectively provided minimal downtime resurfacing and deep dermal heating, promoting collagen remodeling. However, the study was limited by its focus on a specific condition and may not generalize to all potential applications.
Frequently Asked Questions
What is the fractional skin resurfacing FSR applicator used for?
It is used for skin resurfacing and tightening, particularly for treating acne scars and improving skin texture.
What specialties typically use this device?
Dermatologists and cosmetic surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for skin resurfacing and tightening, especially for conditions like acne scars.
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.