FDA Clearance Timeline
Earning FDA clearance and bringing illumiflow to market before our competitors isn’t just a point of pride, it’s proof of quality. While we developed the highly scrutinized technology that earned us 510(k), many of our competitors have since earned the same designation by copying our tech, making them “predicate devices"
So, they aren’t held to the same standard as the original before they sell to the public (read more about that and more on our post here).
Further, it takes time and capital to create an infrastructure and customer support system so keep in mind not all FDA cleared laser cap brands are created equal. In fact, the more recent the FDA clearance, the less likely they will be around to honor their product warranty and return policies.