Hair Loss Device

Icegoddess · ‎03-19-2010

This may not be news, but HSN has the Capillus 202 Laser Hair Cap. Not sure if that's the model @SilleeMee uses or not. It's $1699 + $5.50. Quite the investment, but if you're wanting a serious device. You would think they would waive the s/h on such an expensive item.

ETA: Funny, Dr. Denese did a promo for it. Wasn't it Dr. Denese that also did a promo for the Hairmax Headband?

Also, I thought FDA cleared just meant that it was safe for the intended purpose. This guy is saying it also indicates efficacy. Is that true?

phoenixbrd · ‎03-27-2010

@Icegoddess This product works depending on the reason why you are experiencing baldness...that is my understanding. So when you purchase, it might or might not work depending on your specific problem. It is an expensive risk...but worth it if it is the right strategy for you. @SilleeMee is our resident expert, and hopefully can add some insight. I agree...if you are spending $1700, why add a $5 shipping fee. This is the midrange model and usually retails for 2K.

"...based on the existing clinical evidence published on authoritative sites like PubMed, as well as feedback from a range of consumers across a variety of products, it seems like low-level laser therapy could represent a viable option for those suffering from androgenetic alopecia."

There are positive/negative reviews for this product and the general time it takes to see results is 3-6 months...you must continue to use treatment, or you could lose any benefits you might have gained.

It is also my understanding that FDA clearance indicates safety of use, not efficacy. I doubt a hair loss product could be guaranteed as to efficacy as there is more than one reason for baldness.

Would love to hear from those who have had experience with this product.

Icegoddess · ‎03-19-2010

@phoenixbrd, I don't think his comment about FDA Clearance meaning efficacy meant that it was guaranteed to work for everyone, but that the FDA was giving the seal because it had been proven to work, and I just don't think that's the case. My understanding is that FDA clearance means it is safe if used as directed. Full stop. It really bothers me when they make more of it than that. It's a flat-out lie.

I, personally, am not considering the device. I have the Hairmax headband, and I'm well aware that it is something that, assuming it works at all, will need to be used forever to maintain the effects. That's just like most any beauty product. And that's a stretch for me price-wise.

SilleeMee · ‎05-22-2016

FDA approval simply means they have determined a product to be safe to use in the general public. There are three classifications, I, II and III. Low level lasers fall into class-II (2) which means it has been demonstrated to come with minimal risks. It's about safety issues, mostly and with that efficacy has been established.

https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved

@Icegoddess @phoenixbrd

I own the CapillusPro cap. The one with the most lights on it...270 laser lights.

Icegoddess · ‎03-19-2010

@SilleeMee wrote:
FDA approval simply means they have determined a product to be safe to use in the general public. There are three classifications, I, II and III. Low level lasers fall into class-II (2) which means it has been demonstrated to come with minimal risks. It's about safety issues, mostly and with that efficacy has been established.

https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved

@Icegoddess @phoenixbrd

@SilleeMee Exactly! So the guy is lying in his presentation.

SilleeMee · ‎05-22-2016

@Icegoddess wrote:
@SilleeMee wrote:
FDA approval simply means they have determined a product to be safe to use in the general public. There are three classifications, I, II and III. Low level lasers fall into class-II (2) which means it has been demonstrated to come with minimal risks. It's about safety issues, mostly and with that efficacy has been established.

https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved

@Icegoddess @phoenixbrd
@SilleeMee Exactly! So the guy is lying in his presentation.

@Icegoddess

I wouldn't say he is lying. He is simply saying, in so many words, that since the device is FDA approved then it has been determined to be safe and effective.

SilleeMee · ‎05-22-2016

There are some laser devices that have lasers on them that are not FDA approved. These kind would be considered to be questionable as for their efficacy because it has not been officially investigated or certified by any organization in authority, like the FDA, for example. @Icegoddess

phoenixbrd · ‎03-27-2010

@Icegoddess I agree with what you are saying about the FDA clearance.

However, as @SilleeMee pointed out not all laser's have the safety approval.

"It is also my understanding that FDA clearance indicates safety of use, not efficacy. I doubt a hair loss product could be guaranteed as to efficacy as there is more than one reason for baldness."

SilleeMee · ‎05-22-2016

@phoenixbrd

Here's what I found on the FDA dot gov site regarding getting a device FDA approved:

" To receive FDA approval for these devices, manufacturers must demonstrate with sufficient, valid scientific evidence that there is a reasonable assurance that the devices are safe and effective for their intended uses."

I interpret that last part as a statement saying that when a product is FDA approved then that means it has to do what it says, in this case, make hair grow. FDA approval is not a guarantee but it is a certification that says it is safe and effective for what it is intended to do.