Candela’s Matrix RF Microneedling Applicator OK’ed for Facial Wrinkle Reduction

Candela Corporation, a medical aesthetic device company, has gained U.S. Food and Drug Administration 510(k) clearance of a new indication for its Matrix system, a radiofrequency (RF) platform for comprehensive skin treatments.
 
The expanded label allows Matrix’s use in percutaneous treatment of facial wrinkles in patients with Fitzpatrick Skin Types (FST) I-IV using its Matrix Pro RF microneedling applicator. The applicator was previously FDA-cleared for general dermatological procedures involving hemostasis and electrocoagulation.
 
The multi-application RF skin platform has three modalities of RF energy to tighten, tone, and improve skin texture through its Sublime, Sublative, and Matrix Pro applicators. Matrix Pro uses short pulse RF microneedling to stimulate production of collagen and elastin, which can result in smoother skin and reduced appearance of facial wrinkles.
 
The applicator features proprietary Depth Intelligence tech, real-time impedance monitoring, and a set of thin, stainless-steel microneedles, which Candela says are the smallest on the market. It delivers a precise amount of energy at one, two, or three skin depths in a single insertion.
 
Matrix Pro, according to the company, is the only RF microneedling device FDA-cleared for percutaneous facial wrinkles that uses an advanced algorithm to continuously measure tissue impedance and make necessary adjustments to pulse duration and power output. This helps the system prevent unintentional fat loss or other undesirable outcomes.
 
The FDA nod for the expanded indication was backed by retrospective study data from 32 subjects undergoing full-face treatments with Matrix Pro to reduce facial wrinkles. The study showed “clinically meaningful” improvement of facial wrinkle appearance based on blinded evaluation of the treatment photos.
 
Further, 94% of subjects rated their outcomes as “much improved” or “very much improved,” Candela 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,” said Geoffrey Crouse, Candela’s CEO. “This clearance provides healthcare providers and their patients with a reliable, clinically validated treatment option for facial wrinkles. Our Matrix Pro applicator with its expanded facial wrinkle indication, further combined with the unique treatment capabilities of the Sublime and Sublative applicators, exemplifies our unique approach, integrating state-of-the-art research and development of multi-modality solutions to deliver superior results.”