This year we’ve been telling you about F1030, a new tattoo aftercare cream that has been developed by specialist wound-care experts Flen Health. This month, the company have confirmed that the cream is to have its medical device classification upgraded.
Due to F1030’s unique formulation, and because its developers very much see the tattoo as a wound, Flen Health is now seeking a ‘Class IIa’ classification.
So, what does this mean?
This new classification will increase F1030’s claims and give the product an even greater point of difference compared to competitor products – most of which are predominantly cosmetic and do not have to demonstrate the same level of clinical proof.
Plans for a 2018 launch.
Following a successful initial UK launch within the tattoo community this summer, Flen Health has taken the decision to relaunch the product in 2018, withholding sales temporarily, while it gathers additional clinical evidence via F1030 evaluation forms, enabling F1030 to get approval from the relevant notified body.
Why this is a good step for the tattoo industry.
The developers of F1030 are passionate about gaining an official medical status for this product. The processes needed to secure this high level of classification might mean that customers have to wait slightly longer to get their hands on it, but when it finally arrives, F1030 will be backed by clinical proof not present with other aftercare creams on the market.