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 clarify labelling claims. In some cases, information provided herein is intended to provide educational exposure to the results of clinical studies but does not suggest that Medical Wave is endorsing any such off-label treatments. 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. The D-Actor 50, 100 and 200 are Class 1 devices. The Duolith SD 1 Ultra is a Class ll device.