Merz Ultherapy

Ultherapy is the treatment name for the Ulthera System, a micro-focused ultrasound device developed by Ulthera, Inc. and now sold by Merz Aesthetics. Focused ultrasound at 4, 7 or 10 MHz forms small points of thermal coagulation at a set depth under the skin, and the same transducer produces a B-mode image down to 8 mm. FDA granted the original De Novo request, DEN080006, on September 11, 2009 for the Ulthera System model 8850-0001 with an eyebrow lift indication. Later 510(k) clearances added lax submental and neck tissue in 2012 (K121700), the DeepSEE imaging indications in December 2013 (K132028) and lines and wrinkles of the décolleté in 2014 (K134032).

A complete system is the UC-1 control unit, the UH-2 DeepSEE handpiece and cable, interchangeable transducers, and the UK-1 USB access key, without which the software will not treat. Six DeepSEE transducers are labeled for the system. Their names give frequency first and focal depth second: DS 10-1.5, DS 7-3.0, DS 7-4.5 and DS 4-4.5, plus narrow versions DS 10-1.5N and DS 7-3.0N, which scan 14 mm instead of 25 mm.

Merz now sells a redesigned console, Ultherapy PRIME. The FDA comparison for PRIME describes this original console as having a 15 inch, 4:3 touchscreen at 1024 by 768, Windows XP and a weight of 22 lb. PRIME has a wider, sharper 18.5 inch display. Both use the same transducer family, so the screen is the quickest tell.

Each transducer carries a fixed treatment line capacity, the screen shows lines remaining against that total, and at zero the system displays a transducer out of lines message until it is swapped. Transducers also have printed expiration dates. List every transducer by type with its remaining lines and expiry, confirm the access key is included, and photograph the control unit serial label, the software version screen and the handpiece cable.