| TGA Action ID |
RC-2026-RN-00627-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Renuvion APR Handpiece
Renuvion APR Handpiece (15cm) Single Port
Catalogue Number: APYX-15-SP
Renuvion APR Handpiece (15cm) Twin Port
Catalogue Number: APYX-15-TP
Renuvion APR Handpiece (27cm) Twin Port
Catalogue Number: APYX-27-TP
Instruction for use: MC-15-451-003A Rev 4 |
| ARTG Number |
334409 |
| Unique Device Identifier (UDI) |
APYX-15-SP -(01) 00607151050146 (10) XXXXXXXXXX (11) YYMMDD (17) YYMMDD, APYX-15-TP – (01) 00607151050153 (10) XXXXXXXXXX (11) YYMMDD (17) YYMMDD, APYX-27-TP – (01) 00607151050160 (10) XXXXXXXXXX (11) YYMMDD (17) YYMMDD |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Apyx Medical has updated the labeling for the Renuvion APR Handpieces to align with an update to the intended purpose statement in the Australian Register of Therapeutic Goods (ARTG). To ensure devices supplied to the Australian market are in compliance with the Essential Principles, new Instructions for Use (IFU) MC-15-451-005A have been created for the Renuvion APR Handpieces. |
| Instructions for Customers/Users |
Customers are to:
- Review the updated IFU at https://eifu.apyxmedical.com/
- Discard any printed IFUs packaged with the device. |
| Action Commencement Date |
20/08/2026 |
| Responsible Entity |
|
| Contact Information |
AUNZvigilance@ul.com - Emergo Australia |