Zeltiq Aesthetics, Inc. v. BTL Industries, Inc.

ORDER DENYING MOTION FOR PRELIMINARY INJUNCTION

I. INTRODUCTION

Plaintiff Zeltiq Aesthetics, Inc. (“Zeltiq”) filed this action against Defendants BTL Industries, Inc. . and Saturn Consulting LLC dba Monarch Laser Services (“Defendants”). Zeltiq alleges that Defendants falsely advertised that a medical device manufactured by BTL was approved by the federal Food and Drug Administration (“FDA”) to be used for fat reduction and body contouring. Zeltiq asserts claims under the Lanham Act, 15 U.S.C. § 1125 , and claims for unfair competition under California’s Business and Professional Code § 17200 and Massachusetts General Laws ch. 93A § 2. Zeltiq filed a Motion for Preliminary Injunction (“Motion”). The Court held a hearing on the Motion on March 14, 2014, at 9:30 a.m. For the reasons explained below, the Motion for Preliminary Injunction is DENIED.

II. BACKGROUND

A. FDA’s Premarket Approval and 510(k) Clearance

In 1976, Congress amended the federal Food, Drug, and Cosmetic Act (“FDCA”), *1092 which previously only regulated food and drugs, with the Medical Device Amendments (“MDA”), 90 Stat. 539 , 21 U.S.C. § 301 . The MDA “classifies medical devices in three categories based…