Candela, a medical aesthetic devices developer, has received expanded 510(k) clearance from the US Food and Drug Administration (FDA) for its Matrix multi-application radiofrequency (RF) skin platform.
The Matrix system, designed for comprehensive skin treatments, is now approved for the percutaneous treatment of facial wrinkles in patients with Fitzpatrick Skin Types (FST) I-IV using the Matrix Pro RF microneedling applicator.
Candela, which is based in Marlborough, Massachusetts, had previously received FDA clearance for Matrix Pro for use in general dermatological procedures involving haemostasis and electrocoagulation.
The Matrix multi-application RF skin platform offers three distinct modalities of RF energy to address skin tightening, toning, and texture improvement across various stages of ageing. These modalities are provided through the Sublime, Sublative, and Matrix Pro applicators.
The Matrix Pro applicator uses short pulse RF microneedling to stimulate collagen and elastin production, leading to smoother skin and reduced facial wrinkles.
Equipped with Depth Intelligence technology and real-time impedance monitoring, the Matrix Pro features an array of the thinnest stainless-steel microneedles available.
The design allows it to deliver a precise amount of energy at one, two, or three different skin depths with a single insertion.
The Matrix Pro is said to be the only FDA-cleared device for percutaneous facial wrinkles and utilises an advanced algorithm to continuously measure tissue impedance, adjusting pulse duration and power output as needed.
Candela CEO Geoffrey Crouse said: “Achieving FDA clearance using the Matrix Pro applicator for wrinkle reduction is a testament to our rigorous testing, clinical validation processes, and dedication to advancing outcomes through proven science and technology.
“This clearance provides healthcare providers and their patients with a reliable, clinically validated treatment option for facial wrinkles.”
FDA’s clearance for the new indication of the Matrix Pro applicator is supported by retrospective study data involving 32 subjects who received full-face treatments aimed at reducing facial wrinkles.
The study showed a clinically meaningful improvement in the appearance of facial wrinkles, based on blinded assessments of treatment photos.
Furthermore, 94% of the study participants reported positive feedback about their treatment outcomes.
In July last year, Candela secured Health Canada clearance for the new Profound Matrix System.
