The FDA cleared Eclipse MicroPen EVO™ is quickly becoming the industry standard of microneedling devices. The finished product is a result of meticulous planning, design, redesign, and ultimately production. Above all, it is a device that was built with both the physician and patient in mind. From idea conception through FDA clearance and launch, our mission has been to bring aesthetic physicians and providers the next generation of microneedling devices. The Eclipse MicroPen EVO – microneedling evolved.
In 2016, the FDA made the decision to require all microneedling pen companies to obtain Class II clearance. Eclipse, the leader in the industry at that time with the original Eclipse MicroPen and then the MicroPen Elite, went into development mode on MicroPen EVO.
The first step was to ensure that what physicians loved most about the previous MicroPens was included and improved upon in the future device. In addition, features and specifications that would position the EVO as a best-in-class device were identified to be included in the future design. It was also at this time that the concept of the industry-first decontamination chamber to be used in conjunction with the MicroPen was born.
Eclipse design engineers set out to make a platform that is expandable as future enhancements and technologies became available. With a heavy focus on the ergonomic nature of the MicroPen, usability, line of site, and easy access to the cartridge all received special attention as designs were adjusted prior to a prototype being made.
Incorporated in the original prototype, even at this early stage, was the offset head which allows for an increased field of view for the physician while performing microneedling. The end result is a microneedling device that feels and works like the superior medical device it was designed to be.
The final prototype truly excited Eclipse as the full potential of what EVO could become once launched was no longer just on paper. We were getting to hold the future of microneedling in our own hands.
From there, the rigorous performance testing, verifications and validations that are necessary for FDA clearance began. And then, COVID-19 stopped the entire world. Testing was put on hold while the industry slowed down or stopped course to correct and address the current pandemic. Delayed but not daunted, the testing ramped back up in the late summer of 2020.
In total, dozens of performance tests and validations were performed, culminating in the premarket submission of almost 1,000 pages to the FDA in October 2020.
Which leads us to today. Already, physicians and practices are seeing that EVO is delivering the results patients expect while exceeding the experience of the staff tasked with performing the procedures. We are proud of all of the hard work and ingenuity that has gone into the FDA clearance and launch of the Eclipse MicroPen EVO. It is Microneedling EVOlved.
To learn more about the MicroPen EVO, click here.
To see it, click here.
To schedule an in-person meeting with Eclipse to see the new EVO, click here or call 1-800-759-6876.