We are reaching out to share an important update regarding the labelling and Instructions for Use (IFU) for certain Elite devices purchased between 22 April 2022 and 13 August 2024. 

What is the update?  

The Hydrafacial Elite device is available in two versions—one classified as a medical device and one as a non-medical device. The device itself remains exactly the same in design, performance, and functionality. The only difference lies in the intended use and the accompanying labelling/IFU. 

During a recent review, we identified that some devices were shipped with labelling that did not reflect the correct intended-use version (non-medical). To ensure documentation is aligned with the appropriate regulatory classification, we are providing updated labelling and IFUs for your device. 

Does this affect device safety or performance? 

No. There are no modifications to your device. We have received no reports of adverse effects, malfunctions, or safety concerns related to this matter. This update is purely administrative to ensure your accompanying documentation accurately reflects the device’s qualification as a non-medical device. 

What do you need to do? 

Please take a moment to: 

- Replace the current IFU with the updated version provided, see below for instructions.

- Apply the enclosed updated labels. 

- Fill out the following form:

If you have questions or need additional labels/IFUs, our team is here to help. Please contact internationaltechsupport@hydrafacial.com. 

Thank you for your partnership and for your prompt attention to this straightforward update. We appreciate your continued trust in Hydrafacial and remain committed to supporting you and your business.