Press Release – iGrow LLLT Helmet Receives FDA Clearance
Snippet from the press release:
Apira Science, Inc. recently earned 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its iGrow® Hair Growth System, which is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V. The iGrow is currently available by prescription only.
Read the rest — Apira Science’s iGrow In-Home, Hands-Free Hair Growth System Earns FDA Clearance
Just another low level light laser. There must be money in selling these! Remember, FDA clearance is different from FDA approval. All this is saying is that this can be sold because it is safe, not that it is effective.
For clarification purposes, medical devices (of which the iGrow Hair Growth System is one – a ‘Class II’ medical device) are CLEARED by the FDA. Food and Drugs are APPROVED. The FDA WILL NOT either APPROVE or CLEAR anything unless its EFFICACY is PROVEN through mandated CLINICAL TRIALS. The iGrow Hair Growth System is not only PROVEN to GROW HAIR, but is actually THE most EFFECTIVE hair growth product on the market… exceeding topicals and even pharmaceuticals. Check out our website at: http://www.igrowlaser.com to view a Low-Level Laser Therapy clinical study, and also the data and results of our iGrow clinical trial, which more than substantiates its EFFICACY.
Here is the FDA site for those that would rather learn from the FDA and not just take the word of the advertisement/comment above —
https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194460.htm
The FDA does “approve” some medical devices. Your laser is “cleared” because it is like a similar device on the market, not because it has provided assurance of effectiveness.
To Nick: your comments are pure hogwash my friend. The igrow helmet has only about 21, 5mw focused laser modules and about 30 LEDs which make it IMPOSSIBLE to give full scalp coverage from such a small number of lasers which are held stationary over the scalp. LEDs doing nothing substantial for the hair.
And to say that your igrow helmet is more effective than finisteride, dutasteride or 5% minoxidil is absolutely false. And for you to state it as such,shows your ignorance of these medications and/or your shady sales practices.
Go back to the drawing board and add at least 100+ modules to your design, then we will talk! Lol!