Deprecated: The each() function is deprecated. This message will be suppressed on further calls in /home/hairsite/public_html/hair-loss/functions.php on line 155
Hair Loss Forum - The cure is finally here!

March 2017 - Trending Topics in our new forum

 Stem cell hair restoration results - Dr. Cole vs Histogen vs RepliCel.
 Dr. Paul Kemp, CEO of HairClone answers questions about follicle banking.
 RepliCel year 2017 forecast for RCH-01 cell based hair regeneration.
 Dr. Cole to start stem cell hair restoration trial in the US.
 Dr. Umar's 6500 grafts life saving repair procedure for transplant victim.
 FUE donor harvesting, what you must know when choosing a clinic.
 Dr. Koray Erdogan raises the standard in FUE artistry skills.
 Dr. Arvind on how to formulate your own toxic free shampoo.
 Conference & FREE hair restoration consultations; cities worldwide.

This is a READ ONLY forum.
Access our brand new platform at HairSite New Forum to continue the discussion on these topics that you are interested in. All contents and discussions have been transferred to our new forum at
  HairSite New Forum

Log in | User | Register


25.09.2014, 18:26

The cure is finally here! (Hair Loss Supplements)

JamesJ is located in [NA] and he is available to meet: NO

Post reply

25.09.2014, 23:17

@ JamesJ

The cure is finally here!

I'll admit not reading past the content of the link containing 'laser' and 'fda approved'

From Jotronic's posts starting at "not true" (discussing acell), tells the story well I think....

Over the years various industries have noted the weight and effectiveness of the words "FDA Approved". It injects a sense of confidence and trust that the consumer can feel good about. If the FDA "approves" of something, it must be an indicator that the product is not only safe but it does what it claims to do.

Remember the laser hair restoration fad from several years back? The lasercombs, the helmets, the doohickys? There was only one company that received FDA 510K clearance for their product; the Lexington Laser Comb. Once that happened it opened a flood gate of competing products stating that the technology (note, not their own particular product)was "FDA Approved". This was an obvious lie but it was very effective because I had countless people calling me saying that they were told their laser thingy was FDA approved and I had to explain why it was not. It was a massive waste of my time but I at least helped to educate a few people about these pieces of junk. Turns out, they are no different than laser pointers. Same class of laser, same wattage variances, no different than a laser pointer you can get from Office depot for ten bucks. The amount of laser cap BS at the ISHRS conference last month in San Francisco, in the vendor section, was a joke.

The laser comb was cleared by the FDA with a 510K clearance because it was engineered and built in a similar fashion with no unique technology to any similar products that were marketed before 1976. In 1976 congress granted the FDA governing authority over medical devices. Problem is, before 1976, there were so many products on the market that the FDA could not possibly hope to take them all off of the market and evaluate each and every piece of medical equipment for an actual approval. So a 510K clearance was created and is essentially a grandfather clause that allows any new product to gain clearance if it shows "substantial equivalence" to products ALREADY ON THE MARKET BEFORE 1976!

This means that in order to gain clearance, regardless of the super human properties that the product may have, the manufacturer must downplay their product as being no different than anything else on the market before 1976. They have to show similar manufacturing, similar materials in the engineering of the product and a similar intended use. The moment they mention anything outside of these parameters as being one of the intended uses for the product, BAM!, they set the whole process back by years, and millions of dollars, in order to prove the claims.

510K clearance is the fast track to being allowed to sell a medical device in the US (and this is a medical device). Had Acell tried to push this through the FDA as being a regenerative medical device then they would have to prove without a shadow of a doubt that indeed that is what this product does, which it does not except in some cases. What ACell CAN do, but not always, is help to create a more ideal environment for healing.

What Acell the company does or does not do or say on their website is irrelevant. YOU stated "FDA approved for regenerative medicine". No where on the FDA website does Acell show FDA approval for ANYTHING much less "regenerative medicine". It is FDA cleared under the 510K clearance protocol for wound management and is no different, in the eyes of the FDA, as any other wound management device that has incorporated porcine derived ingredients over the past forty years

hairdar is located in [NA] and he is available to meet: NO

George Taylor: There's your Minister of Science; honor-bound to expand the frontiers of knowledge...
Dr. Zira: Taylor, please!
George Taylor: ...except that he's also chief Defender of the Faith!
Dr. Zaius: There is no contradiction between faith and science... true science!
George Taylor: Are you willing to put that statement to the test?
Cornelius: Taylor, I would much rather...
George Taylor: Take it easy... you saved me from this fanatic, maybe I can return the favor!

Post reply

120100 Postings in 12546 Threads, 6040 registered users
Hair Loss Forum | Admin contact

This is a READ ONLY forum.
Access our brand new platform at HairSite New Forum to continue the discussion on these topics. All contents and discussions have been transferred to
HairSite New Forum

Disclosure: This is an advertising site for our paid sponsors & advertisers. The contents, videos & photos on HairSite are provided by paid sponsors and are not endorsed by HairSite in any way. The recommendations, results, and representations made by our sponsors/advertisers do not reflect the opinions of HairSite. This site is to showcase successful hair restoration results only. It is not the mandate of this site to engage in the discussion of failed, unsuccessful procedures, lawsuits, litigations or complaint cases; comments of such nature, including external links, may be removed from the forum. Notify any false, defamatory, misleading or inappropriate user generated contents for immediate removal from the forum. Also read Terms of Use & Privacy Statement |  HairSite advertisers: ASMED | Dr. Bhatti | Dr. Bisanga | Dr. Cole | Dr. Hakan Doganay | Dr.Epstein | Dr. Jones | Dr. Halder | Hasson & Wong | Dr. Klein | Dr. Madhu | Dr. Mwamba | Dr. Donald Ng| Dr. Poswal | Dr. Rahal | Dr. Razack | Dr. Reddy | Dr. Umar | Dr. Woods | DHI Global | HDC Clinic | |Lasercomb | Reviva Clinic | Ziering Medical|