HIFU

Licensed since May 2009. Health Canada’s licence 79689 lists the Ulthera System, a Class III medical device, to Ulthera, Inc. The instructions state the use as a non-invasive aesthetic treatment to lift the eyebrow, lift lax tissue under the chin and on the neck, and improve lines and wrinkles of the décolleté; the FDA cleared those three uses in 2009, 2012 and 2014. A licence records Health Canada’s review of the device against its safety and effectiveness requirements for the use filed; it does not establish every benefit, area or duration a clinic advertises.Health Canada · MDALL licence 79689 · Ulthera instructions 1015107IFU Rev D §2.1 · FDA K072505, K121700, K134032

GST or HST applies to taxable cosmetic treatments: 13% in Ontario, 5% where only GST is charged. The clinic prices here are before tax. A treatment for a medical or reconstructive purpose may be exempt when it meets the applicable health-care exemption’s conditions, including who supplies or performs the service; its purpose alone does not establish an exemption.Excise Tax Act · s. 165, Sch. V Pt. II ss. 1, 1.1, 1.2 and 5 to 7, Sch. VIII

Ultherapy combines treatment with ultrasound imaging. Ontario defines diagnostic ultrasound as ultrasound that produces an image or other data, and regulates applying or ordering that energy. DeepSEE visualizes tissue layers and treatment depth, so the imaging step requires applicable legal authority, delegation or an exemption; considering the treatment beam alone does not establish who may operate the whole system. The manufacturer restricts use to properly trained physicians and properly trained people under a trained physician’s supervision. Other provinces set their own rules.RHPA s. 27 · O. Reg. 107/96 ss. 0.1 and 1 · Ulthera instructions 1015107IFU Rev D, front page and §2.1

Not in the figures above. Alam 2010 was supported by a research grant from Ulthera to Northwestern University, its footnote states; Oni 2014 is trial NCT01368835, sponsored by Ulthera; the chest study is the maker’s own. Seoul National University Hospital registered an 18-person trial in 2015, completed that October, with no results or paper listed. This page cites no trial run by anyone else.Alam 2010, PMID 20115948, disclosure · ClinicalTrials.gov NCT01368835 and NCT02368925 · Ulthera instructions 1015107IFU Rev D §6.1.3

During the lines, yes; afterwards, little. The instructions describe momentary discomfort as each line is deposited and tenderness for 2 days to 2 weeks. In Oni 2014 people rated the procedure 5.68 of 10 on the cheek, 6.09 under the chin and 6.53 along the jaw. Clinic pages offer numbing cream, an oral analgesic or nitrous oxide.Ulthera instructions 1015107IFU Rev D §2.5 · Oni 2014, PMID 24990884 · clinic pages