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Important Information for U.S. Customers: Certain devices and references made herein to specific indications of use may have not received clearance or approval by the United States Food and Drug Administration. Practitioners in the United States should first consult with their local Subzero Cryotherapy Aesthetic representative in order to ascertain product availability and specific labeling claims. Federal (USA) law restricts certain devices referenced herein to sale, distribution, and use by, or on the order of a physician, dentist, veterinarian, or other practitioner licensed by the law of the State in which she/he practices to use or order the use of the device.