Yes. EMSCULPT NEO is covered by ARTG entry 329193, sponsored by BTL Medical Technologies Pty Ltd. The current public summary identifies an active Class IIa device entry.
What does the record cover?
The intended purpose includes body reshaping, muscle conditioning and strengthening, fat reduction, muscle-spasm relief and pain alleviation using the combined radiofrequency and electromagnetic system. The record also describes pelvic-floor strengthening for urinary incontinence when the optional EMSELLA chair applicator is connected.
What does inclusion mean for a patient?
ARTG inclusion is the Australian regulatory status of the relevant device. It is not TGA endorsement of a clinic, a guarantee of results or a substitute for checking individual suitability. The device configuration, instructions and intended use still matter.
Where can I check the source?
Read the TGA ARTG 329193 record and linked public summary, checked on 17 September 2026. The Australian record is separate from US FDA clearance.