Squid Healthcare Announces FDA 510(k) Submission for EyeMask MD

The masks were developed for the management of 1st and 2nd degree partial thickness burns, donor sites and traumatic and surgical wounds.

Squid Healthcare's EyeMask MD
Squid Healthcare's EyeMask MD
Courtesy of Squid Healthcare

Squid Healthcare has submitted a 510(k) pre-market notification to the U.S. Food and Drug Administration (FDA) for its EyeMask MD.

Squid Healthcare is a medical aesthetic company focused on periocular wellness for post-surgical and nonsurgical procedures.

The submission includes biocompability and bench mark data for over-the-counter use of EyeMask MD for minor abrasions, lacerations, minor cuts,  minor scalds and burns, as well use under the supervision of a health care professional for the management of 1st and 2nd degree partial thickness burns, donor sites and traumatic and surgical wounds.

“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 postprocedure experience,” said Ronald Mancini, MD, oculoplastic surgeon and co-founder of Squid Healthcare.

The EyeMask MD is not yet available for purchase, pending the FDA authorization.

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