Frequenty Asked Questions
Purchasing a medical device - the law
Q). Can anybody import and sell a Class II, III or IV Medical Device in Canada?
Q). What Laws govern Class II, III or IV Medical Devices in Canada?
Q). If a Class II, III or IV Medical device has CSA Approval but does not have Health Canada Approval, is it legal to be in Canada
No…CSA is an electrical safety approval only and has nothing to do with Health Canada Medical Device Licence approvals.
Q). What type of Class II, III & IV Aesthetic Medical Device be legally used on humans in Canada?
Only Health Canada Approved Class II, III, IV Medical Devices can be used on humans in Canada
Q). Can any Class II, III & IV Aesthetic Medical Device be legally imported into Canada?
No, Only Health Canada Approved Class II, III, IV Medical Devices can ONLY be Imported into Canada and ONLY by a Licenced Health Canada Medical Device Establishment.
Q). What type of Class II, III & IV Aesthetic Medical Devices, can be legally sold, advertised or offered for sale in Canada?
Only Health Canada Approved Class II, III, IV Medical Devices can be offered, advertised for sale, or sold into Canada
Q). How do I know if a Class II, III or IV Medical Devices has a Health Canada Licence?
Q). What common Aesthetic Medical Devices are considered Class II, III or IV Medical Devices in Canada?
IPL, Laser and RF devices are all Class II & III and must have a valid Health Canada Medical Device Licence Number.
Asclepion MeDioStar NeXT
Q). What is a Fiber Bundled Spot Size and why is it used on the MeDioStar NeXT diode laser Handpieces?
A fiber bundled spot size is a unique arrangement of tightly bundled glass fibers that provide consistent delivery of the laser beam throughout the entire spot profile thus eliminating any “hotspots”. The fiber bundle is capped with a sapphire tip to seal out any possible contaminants and allow for longevity of the tip and quick & easy cleaning.
Q). How effective is the 940nm Vascular Handpiece for Leg Vein treatment ?
The 940nm wavelength is an ideal wavelength at an ideal spot size of 4 x 3mm, for closing deeper Vascular lesions, with safer and more effective absorption of both levels of oxy and (reduced oxy vessels, where 1064nm has virtually zero absorption).
Q). Does “Pain Free” hair removal on the MeDioStar NeXT diode laser really work?
YES! Clinically proven study results with the easy to use “SmoothPulse” settings and the 14 x 10mm Standard Handpiece, have provided excellent results for both coarse and fine hairs on Skin types I to V.
Q). What Skin Types can be effectively treated with the MeDioStar NeXT diode laser ?
Both built in quick settings and advanced professional settings allow effective hair removal treatments of skin types I to V.
Q). What Handpiece options are available on the MeDioStar NeXT diode laser ?
A 14 x 10mm Standard Handpiece, an Optional High Powered Handpiece or a special Vascular Handpiece can also be added.
Q). What makes this laser the world’s best-selling diode laser for Hair Removal?
High quality German engineered technology that offers multiple treatment options of; 810 & 940nm high-speed hair removal, along with the option of Pain-Free hair removal and a special Vascular Handpiece for 940nm Leg vein treatments.
Kontur MD
Q). How many treatments?
The new KONTUR MD Multi Polar RF device produces almost instant noticeable tightening and contouring effects from the first treatment, and long term lasting anti-aging skin laxity improvement after 6-8 treatments
Q). How does it tighten skin?
The absorption of the RF energy, noninvasively, causes the deeper dermal and subdermal tissues to heat up, producing a localized and controlled heat injury as well as some structural molecular changes.
Q). What is MultiPolar RF with EASY-MODE and EXPERT MODE CMF/TOP Functionality?
Face and neck specialized handpiece UNIQUE "Wrinkles" - specialized mini-handpiece. The RF energy, with CMF/TOP functionalities, when diffused from the multi-polar poles, through the treatment handpiece, is having a longer acting effect for skin tightening and simultaneous active drainage.
Q). What is Easy Mode?
EASY MODE will provide preset parameters for the treatment of different areas of the body or face, adjusted to skin tone, flaccidity (laxity of the skin), and more. Expert Mode will allow users to choose their own parameters manually.
The CMF/TOP Functionality (software controlled) – The new KONTUR MD Multi Polar RF device is using a two fold unique technology: The CMF functionality (optional in EXPERT MODE): Cycling Multi- Frequencies - alternating between timed cycles of 0,5MHz, 0,75MHz and 1MHz, for accessing different depth penetrations, draining and "massaging" effect, is also combined with The TOP functionality (optional in EXPERT MODE): Timed Oscillating Polarity - switching the polarity of each electrode, in a sequence, back and forth to positive or negative, to ensure the warming of tissue always at the center of the treatment handpiece). Changes in polarity can be set from a 1 second cycle to 2, or 3, 4, or up to 5 seconds cycle for specialized treatments. It is suggested that if short timing settings are used (1 or 2 seconds) for thinner areas of the body as an example, the targeted tissue shall have some quick time to cool down between the pulse changes (in the same way the IPL technology uses the "pulse interval' (longer or shorter) between pulses in one single flash). If this is the case, we can also assume that the use of the longer time interval between the polarity changes (polarity stays constant for a longer time) may benefit the larger fat deposits in reaching the optimal thermal goals faster and more efficiently. This unique, combined and synergetic use of the RF energy ensures both the homogenous warming up and tightening of the treated area, a larger and deeper penetration of the effective energy, when added to the draining and massaging effect of the handpieces on the outer skin surface ensure better lipolisys outcomes (Metabolically breaking down the triglycerides). Technology – Skin Tightening Unique Features.
Q). What is MULTIPOLAR RF with novel DVTP with EASY-MODE and EXPERT MODE CMF/TOP Functionality?
The Multi Polar RF technology with the novel DVTP (Deep Volumetric Thermal Profile) is more effective, specifically for re-shaping/ contouring large body areas with fat and cellulite, because more the energy is getting deeper into the tissues, more efficiently, instead of superficially moving along the shortest path between two electrodes (as in the bipolar modality).
It may cause only very minimal pain and/or discomfort compared with previous devices using the Monopolar or Bipolar technologies. This novel configuration of the RF MultiPolar Kontur MD, enables the user to manipulate both the 3 different frequencies and the polarity of the 3 or 6 electrodes.
These quick changes of the frequencies through alternating 2 to 1 polarized electrodes (multi polar modality) are preset for most efficiently targeting the exclusive use for treatment of the larger body areas with bigger fat deposits.
These specific settings for the body contouring and cellulite (when the main target is the fatty tissues versus the face/neck treatment settings) are quickly building up a unique profile of thermal energy (called DVTP), with deeper penetration and higher temperatures to efficiently target the adipose tissue, at the same time also dramatically reducing the pain concerns.
