That was an excellent post. One of the very best I've ever read on a forum. Funny too.

I have several 510k s to my name for medical devices I've designed and built over the years. While it was certainly convenient and cheap to get approval on my devices using the "substantial equivalence" argument, it is true that there is room for abuse. Laser combs are only a SMALL example of this abuse.

Keep in mind, however, that the 510k process also allows good and useful products to receive approval much faster than without it.

I was never a fan of gov't regulation because it provides a false sense of security to the general public and makes them become lazy about researching products and thinking for themselves. How else could a product like laser combs not be laughed off the market? By "approving" the product the gov't has given the public the false perception that it has consistent and demonstrable efficacy.

Forum viewers and contributors are obvious exceptions to this rule. Gov't intrusion into invention and development styfles innovation.

It seems there will always be a good and bad side to every process. For this reason, it is up to the public to be EVER vigilant when opting for anything medical or otherwise. A good place to start is common sense. If what is being offered seems too good to be true...then it is!
The second place to start is to examine the credibility of those offering the "fantastic product". If they seem like sleezy salespeople, then step back and re-evaluate.

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Feller Medical, PC
Great Neck, NY

Dr. Alan Feller is a member of the Coalition of Independent Hair Restoration Physicians

Providing Hair Transplants and Platelet Rich Plasma (PRP) Treatments

How does the public do this Dr. Feller? What you suggest is virtually impossible. The public cannot submit products to blind studies and peer review to determine if a product is safe or not, effective or not. Only the government is well suited for that role, and the FDA has again and again let the public down. Not only does it approve medical devices which should never be approved (who knows how many people will waste their money on these lasers), but it approves drugs that actually kill - Vioxx comes to mind. Heck, the FDA has the public believing that generics are always the exact equivalent to the brand drug, and that is sometimes not true. Sometimes not even close. Just my two cents for the evening.

Hoping

I think what Dr. Feller means here is to know all the facts before YOU - part of the public - take the leap forward. This is the same advice we give here all the time regarding hair transplantation. Research and educate yourself. The more you know, the more you can make an informed decision.

Think of a resarch paper or thesis. One always had to consult a number of sources to become properly informed in order to make or prove a point.

The FDA is just one source. Of course, extensive research into 510k approval shows what Joe has already posted above. HOWEVER, other sources need to be consulted to get the bigger picture.

Proceed into anything with knowledge and wisdom. The only way to do that is by educating yourself first, despite any hype that you might hear.

Bill

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Managing Publisher of the Hair Transplant Network, the Hair Loss Learning Center, the Hair Loss Q&A Blog and the Hair Loss Forum and Social Community

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To learn about how I restored my hair, view my my hair loss website.

Remember, true beauty radiates from within, not from the skin.

I am not a medical professional and my words should not be taken as medical advice. All opinions and views shared are my own.