While their product is FDA-Cleared, there’s got to be a red flag coming up in your mind when you hear that an entire laser cap business popped up overnight with the infrastructure necessary to properly conduct quality control and comply with the many regulations of the laser cap industry. And while many companies have sprung up, using illumiflow as the predicate for FDA clearance, Kiierr’s certificate came with a very interesting notice:
“Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.”Kiierr FDA Clearance Certificate
When the ticket price is low, that’s great—but when the ticket price is kept suspiciously low, you know something along the way is being sacrificed.
“Fast” isn’t good when it comes to start-up laser cap brands
Running a laser cap company is expensive by nature, requiring infrastructure to support a team who can tend to endless assessment of emerging and current technologies, science and health, constant customer service, and supplying concerns, all while remaining compliant to regulations. Meanwhile, to some companies, FDA clearance is just another startup cost.
The most obvious signs that something could be a little off:
- They claim to have been in business for “3 years,” but they only got their FDA clearance in September of 2018.
- The badges on their homepage for CNN, DATELINE, TODAY, The DOCTORs just link to their product page, not to actual press information.
- Since their recent FDA clearance, they’ve flooded the internet with pop-ups and ads, a clear message of where time, energy, and money is being spent: marketing. While we can’t be sure what’s going on at Kiierr headquarters, in general when so much is spent on marketing in the early days of business, areas such as product safety or quality control can take a hit. One expense to consider for a laser cap business is customer service: to the people who purchase and need guidance to see results.
Established companies like illumiflow, Capillus, and iRestore are safe bets for both quality, safety, and service, so if you’re buying your first laser cap, it might make the most sense to stick to these solid brands. Illumiflow is very open about taking FDA clearance seriously—you can read their blog post about it here.