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TGA Action ID	RC-2025-RN-00115-1
Type of Product	Medical Device
Product Name/Description	Er YAG Laser and PETIT LADY HANDPIECE Serial numbers: AT414L031, AT414M013, AT415F002, AT415D013, AT415J007, AT414J021, AT415D004. AT417G001, AT418C005, AT415M003, AT417J012, AT419L012, AT421D002, AT419J003. ARTGs 227865 & 230419 (cancelled)
ARTG Number
Action Type	Recall
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 for these indications. The Petit Lady Handpiece was intended to be used for genitourinary indications and vaginal rejuvenation; however, this is no longer approved for use and the devices are to be removed from the Australian market. This version has been distributed to salons since 2014. As a consequence, specific indications in the IFU related to the stress urinary incontinence and vaginal relaxation syndrome use of the devices have been removed from the IFU.
Instructions for Customers/Users	Customers are to: -Inspect their inventory immediately and quarantine affected Petit Lady Handpiece stock on hand to prevent further use. -Return affected stock on hand with the completed response form to the address in the customer letter. -Discard the current Instructions for Use (IFU) and replace them with the updated IFU, which will be provided with the Customer Letter.
Action Commencement Date	3/03/2025
Responsible Entity	AC Newco Pty Ltd
Contact Information	0457588797 - Steve Campbell