| TGA Action ID |
RC-2025-RN-00032-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
XS Dynamis and SP Dynamis Laser System
Model numbers: M002-2A and model M021-4AF/3
Multiple serial numbers
ARTGs 239033, 241672 |
| ARTG Number |
239033, 241672 |
| Action Type |
Product Defect Correction |
| Action Level |
Retail |
| Hazard Classification |
Class II |
| Reason for the Action |
The TGA has determined as part of a post market review that there is insufficient clinical evidence for energy-based devices to be used for vaginal rejuvenation in Australia.
Er:YAG non-ablative SMOOTH mode treatments for GSM, SUI, VRS, & Prolapse have been removed from the list of approved indications for Fotona systems on the ARTG.
This Product Defect Correction does not affect the use of Fotona systems for ablative gynaecological procedures (such as removal of cervical warts and surgical removal of excess tissues) and does not affect any other Fotona products.
This change came into effect on 15 November 2024. |
| Instructions for Customers/Users |
Customers will be provided an updated IFU that does not include references to vaginal rejuvenation procedures.
This action has been finalised on 20/5/2025. |
| Action Commencement Date |
7/02/2025 |
| Responsible Entity |
|
| Contact Information |
1800 888 983 - Innovative Medical Technologies |