DALLAS–(BUSINESS WIRE)–#510k–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.”
About Squid Healthcare, Inc.
Squid Healthcare, Inc., is committed to inventing, developing, and bringing to market innovative solutions to address consumer and patient needs specifically related to periocular wellness. Blepharoplasty is the 3rd most performed cosmetic surgery in the U.S. and globally with a total procedure count exceeding 1.6 million. In addition, up to 10 million non-surgical periocular procedures are performed annually. Squid Healthcare’s goal is to have a positive impact on the lives of consumers and patients, with simple innovative products trusted and recommended by plastic, oculoplastic, and other healthcare and aesthetic professionals.
Forward-Looking Statements
This communication contains forward-looking statements regarding Squid Healthcare’s 510(k) premarket notification to the FDA for EyeMask MD®. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, and there can be no assurance that Squid Healthcare, Inc. will obtain 510(k) clearance from the FDA for EyeMask MD® or as to the timing of any such clearance. Many of these risks and uncertainties are beyond the company’s control, including without limitation, risks relating to regulatory clearance and market acceptance of EyeMask MD®. Squid Healthcare, Inc. expressly disclaims any undertaking to update any forward-looking statements set forth herein to reflect events or circumstances after the date hereof, except as required by applicable laws or regulations.
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