Aesthetics spends 60 seconds with CEO of Celluma Patrick Johnson.
First and foremost, ISO certification does not denote approved indications for use. Many LED devices have no medical credentials or clinical studies demonstrating their efficacy. As a medical professional, we believe that you should be using devices that have been certified for medical use, so this should be at the forefront of your mind when choosing a LED device.
The Celluma is FDA-cleared for nine separate indications, six in the area of musculoskeletal pain management and three in skin. Over five years, we collected clinical data on Celluma’s performance and submitted it to the FDA in support of our cleared indications. BioPhotas then obtained its ISO 13485-2016 certification as a medical device manufacturer and the Celluma was CE marked as a Class 11a medical device for all FDA-cleared indications, with the exception of wrinkle treatment, which is not a medical condition according to the EU medical device authorities. Celluma is the only LED device medically CE marked for dermal wound healing.
Historically, the review process of the US FDA and the EU medical device authorities have differed around the element of clinical data. In the US, the FDA typically requires that a device manufacturer provide clinical data on the efficacious performance of their devices – we certainly did. We also used this clinical data and our FDA clearances to support our medical CE mark applications. Whereas in the EU, devices can be approved with the support of general clinical literature. The reason FDA clearance is relevant to the UK is that with the new Medical Devices Regulation coming into force in May 2020, review standards are taking a similar approach advocated by the FDA, and EU device manufacturers will have to provide device-specific clinical data to support their marketing claims. Celluma has already done this.