SCOTTSDALE, Ariz.--(BUSINESS WIRE)--Toro Management, LLC DBA SYLK, the exclusive manufacturer and distributor of SYLK® personal lubricant in the United States, is proud to announce that The Company received its FDA 510(k) Clearance as a Class II Medical Device on March 10, 2016. SYLK® has proven its safety and effectiveness as a personal lubricant and is now cleared as a medical device to market and sell to the masses in the United States. At the present, many consumers are unaware that all personal lubricants being sold in the United States are required to have a Class II Medical Device Clearance and the manufacturer must be registered with the FDA. The successful receipt of our 510(k) Clearance as a Class II Medical Device is a monumental step for SYLK® in the United States and The Company is proud to offer the superior all natural personal moisturizing lubricant on the market today. SYLK® has been sold in New Zealand and Australia since the 1980’s and also has been a trusted product and sold in the United Kingdom since the 1990’s where SYLK® has also received its prestigious CE certification.
Mariessa Mahfouz, founder of Toro Management and CEO of SYLK® comments, “Since acquiring the exclusive distribution rights of SYLK® here in the United States, The Company made a significant financial commitment to move forward with a 510(k) submission to become cleared by the FDA as a Class II Medical Device. The amount of time, dedication, and patience that this process took was extraordinary but we knew that outcome would be well worth the considerable effort. The entire SYLK® team feels so strongly about our product and how SYLK® benefits women and men from all walks of life that this was a straightforward and necessary decision to pursue and successfully secure our status as a Class II Medical Device. We could not have accomplished this feat without the meticulous and professional guidance of Jeff Morgan and Jim Dunning of QPC Services. As our 510(k) consultants, Jeff and Jim exhibited the utmost professionalism, courtesy, and care throughout the entire process.”
Ms. Mahfouz further comments, “As the best all-natural product in its category, we have known all along how safe and effective SYLK® is and our FDA Medical Device Clearance confirms what we have always known. Now, consumers en masse in the United States can enjoy the benefits of SYLK® just as New Zealanders and Australians have for 30 years. New Zealand is a country with one of best reputations on the planet for creating the highest quality natural products. The Kiwifruit Plant Extract from New Zealand, that is the exclusive and differentiating ingredient found in SYLK®, also shares this same reputation. We could not be more thrilled to bring SYLK® as a cleared Class II Medical Device to the U.S. population.”
Toro Management, LLC DBA SYLK (“The Company") is the exclusive manufacturer and distributor of SYLK® Natural Moisturizing Lubricant in the United States and its other territories. “The Company” owns the exclusive distribution rights in the United States, Canada, Mexico, Brazil, Taiwan, and China for SYLK®. SYLK is the premium all-natural personal lubricant that has been sold in Australia and New Zealand since the 1980’s and sold in the United Kingdom since the 1990’s. In the United States, SYLK® is now an FDA cleared Class II Medical Device.