Cryolipolysis skin contouring system [62441] (Cancellation from the ARTG under subsection 41GN(1) of the Act)
Product name
Cryolipolysis skin contouring system [62441]
Sponsor
ARTG
317611
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancellation from the ARTG under subsection 41GN(1) of the Act
Grounds for regulatory action
The device was incorrectly classified as a class I medical device. From the information available the device should be included on the ARTG at a higher classification. Therefore, the certification made by the sponsor under paragraph 41FD(c) of the Act in the application for inclusion is incorrect.