| TGA Action ID |
RC-2025-RN-00090-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
CO2RE System
Multiple serial numbers and product identifiers
ARTG 174946 (cancelled) |
| ARTG Number |
|
| Action Type |
Product Correction |
| Action Level |
Retail |
| Hazard Classification |
Class II |
| Reason for the Action |
The TGA has completed a post-market review of all energy-based devices used for vaginal rejuvenation included in the Australian Register of Therapeutic Goods (ARTG). The review found there was insufficient clinical evidence to support the therapeutic use and long-term safety of these devices.
Specific indications in the IFU related to the genitourinary use of the devices have been removed from the IFU. |
| Instructions for Customers/Users |
Customers are to read the updated IFU, which is attached to the customer letter.
Customers are to discard the old IFU and replace with the updated IFU. |
| Action Commencement Date |
13/02/2025 |
| Responsible Entity |
|
| Contact Information |
kirstenc@candelamedical.com - Syneron Candela |