Patents

UltraSlim® devices and services are provided subject to licensing of U.S. Patent 9,044,595, U.S. Patent 9,498,641, and U.S. Patent 9,808,314. UltraSlim® is a registered trademark of Blue Water Innovations, LLC and cannot be used without permission.

FDA Clearances

FDA clearances include
K150336, K160880, and K180338.

Clinical Information

Clinical Trials

In 2015 multi-site clinical trials (NCT02867150), researchers documented the results that your patients want:

Immediate Results. All patients lost fat immediately -- without dieting, exercise, drugs, or surgery.

Dramatic Fat Loss At Each Visit. Patients lost an average of 1,580cc of fat in just 32 minutes (3.5" combined waist, hips, and thighs). During one visit!

Works For Everyone. Every patient had clinically significant losses at each visit, ranging from 717cc to 4,608cc (1 5/8" to 10" from the waist, hips, and thighs).

A Safer Device. UltraSlim® Professional is the only fat reduction device classified in the lowest risk category as a Risk Group 1 device. There are no side effects, complications, or adverse events.

Durability. Patients seen at follow-up had lost an additional 1 1/8" of fat during the week following treatment. With UltraSlim®, patients lose the fat permanently through a natural bodily function known as "lipolysis", whereby the contents of their fat cells are excreted primarily in their waste. Once you flush the toilet, that fat cannot come back! Of course, patients can gain weight in the future if they consume too many calories.

Research

Listed below are studies demonstrating the power, penetration, and efficacy of UltraSlim®, along with blood chemistry studies which find no increase in serum triglycerides or cholesterol:

• Intra-Surgical Study of Fat Reduction In Vivo

• Placebo-Controlled Trials by Robert H. Burke, MD, MS, DDS, FACS, FICS

• Blood Chemistry Studies by Drs. Ruth and Olaf Rustad

• IRB Clinical Trials NCT02867150

• Comparison of Light Therapy and UltraSlim®

• UltraSlim® Specifications

• UltraSmooth™ Specifications

Novel research currently includes the treatment of lymphedema by vascular surgeon Michael Romberg, MD, FACS and the treatment of surgical wounds by investigator Robert H. Burke, MD, MS, DDS, FACS, FICS.

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