Alma Lasers Australia Pty Ltd - Dermatological carbon dioxide laser system (Cancellation from the ARTG under subsection 41GN(1) of the Act)
Product name
Dermatological carbon dioxide laser system
Sponsor
Date action takes effect
Compliance action
Medical device cancellation - certain devices within an entry
Type of action
Cancellation from the ARTG under subsection 41GN(1) of the Act. Cancellation is limited to some medical devices of the kind and the ARTG is varied accordingly under section 41GO of the Act.
Grounds for regulatory action
The sponsor did not provide sufficient information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of device in the ARTG was subject, and the certifications made are incorrect, or are no longer correct, in a material particular. However, as other devices of the same kind are included under the ARTG entry, the entry has been varied to exclude any accessories / handpieces of the device used for the aesthetic and functional procedures that claim to correct and restore the optimal structure of the vagina and surrounding tissues (vaginal rejuvenation).