The company’s FDA submission is supported by biocompatibility data as well as bench data in support of Over-The-Counter use of EyeMask MD for minor abrasions, lacerations, minor cuts, and minor scalds and burns
The US FDA’s Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Squid Healthcare, Inc., a medical aesthetic company innovating periocular wellness for post-surgical and non-surgical procedures, announced today it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the EyeMask MD®. Pursuant to Section 510(k), once the application has been accepted, the FDA will conduct its substantive review and may request additional information.
The company’s FDA submission is supported by biocompatibility data as well as bench data in support of Over-The-Counter use of EyeMask MD® for minor abrasions, lacerations, minor cuts, and minor scalds and burns, and for Rx use under the supervision of a healthcare professional, for the management of 1st and 2nd degree partial thickness burns, donor sites, and traumatic and surgical wounds, including in the periorbital area.
“We are pleased to announce this important milestone, a key step in bringing EyeMask MD® to the medical aesthetic market,” said Ahmad Tawil, co-founder and Chief Executive Officer. “This is the only FDA authorization seeking product for the management of surgical (e.g. blepharoplasty) and non-surgical (e.g. injectables) post procedure care in the periorbital area. We look forward to working with the FDA throughout the review process and to achieving our goal of an FDA clearance that will lead to commercialization.”
Dr. Ronald Mancini, a world-renowned oculoplastic surgeon and co-founder of Squid Healthcare added that, “The lack of post-surgical patient care leads to reduced patient satisfaction. EyeMask MD®, once approved, will have a positive impact on the lives of our patients and consumers by dramatically changing the post procedure experience.”
Source: Company Press Release