Lasercomb is NOT FDA APPROVED for HAIR LOSS.

[beaner]

On my quick review of the FDA website just now, the difference between a "Pre-Market Approval" and a "Pre-Market Notification" is that only certain kinds of devices (ie Class III) need to go through Pre-Market Approval. Class III devices are those that support or sustain human life and therefore need more stringent testing.

A lower threshold is used for Class I and Class II devices - the Pre-Market Notification.

So from what I have read on the FDA website, a Pre-Market notification is the official sanctioning from the FDA that a device:

(a) does what it is advertised to do; and
(b) is safe for use by the public.

With specific reference to the Hairmax:

(a) it is indicated and may be advertised for the promotion of hair regrowth in males with androgenetic alopecia (because it has the ability to do this); and
(b) is safe to use with no material adverse effects.

I am not sure where Bubka is coming from with his statements that it has been approved only as a "safe, cosmetic" device.

From what I can tell, the FDA has (little "a") approved it for the regrowth of hair.

Let's see how they respond by email.

Oh, and Beaner:

If approved, the FDA will mail you a letter, with an assigned 510(k) number, that says they "have determined that your device is substantially equivalent to legally marketed predicate devices...and you may therefore market the device subject to general controls provisions of the (Food, Drug and Cosmetics) Act" Essentially, when they send you the letter, they are not approving your device, they are saying that your device is much the same as other devices (predicates) already approved by the FDA. You will not receive a certificate from the FDA, but this letter will be available on the FDA database as proof to your customers that your product is approved for sale in the US.

If this device is substantially equivalent to predicate devices that HAVE been FDA approved, isn't the logical extension of this that the Hairmax also meets the approval requirements?

Def

You can look at it that way, but that would then also indicate that the FDA has at sometime in the past approved a laser device for hair growth, which we know it has not. The statements indicating that "they are not approving your device" and "you will not receive a certificate from the FDA" are what makes me think twice about this whole thing.

 

[bubka]

I am not sure where Bubka is coming from with his statements that it has been approved only as a "safe, cosmetic" device.

well given the reply from the FDA, it mentions right in print

"The Federal Food, Drug, and Cosmetic Act....premarket approval... market the device... under the general controls of the act."

thats why before I have quoted what the FDA cosmetic act allows for manufactures to say, which like wrinkle cream, can say that is is for hair loss, and make general claims... however, they cannot say "FDA APPROVED" which hairmax DOES NOT have on their website!!

thus why I have quoted this before:

http://www.cfsan.fda.gov/~dms/cos-lab4.html

 

[bubka]

even more, lets see what a 501K really is:

510(k) Overview

Section 510(k) of the Food, Drug and Cosmetic Act requires those device manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market a medical device. This is known as Premarket Notification - also called PMN or 510(k) . It allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.

http://www.fda.gov/cdrh/510khome.html

to act like this device went through the same type of approval as medical drug or device is total nonsense

 

[Def]

You are just getting caught up in semantics and what you are writing is incorrect, Bubka.

The Hairmax has been (little 'a') approved, authorised, sanctioned by the FDA and Lexington are allowed, by virtue of the 510(k) certificate, to advertise that it promotes hairgrowth without infringing the Food, Drug and Cosmetics Act. What they go on to say in the 510(k) certificate, is that just because it has been approved, it doesn't mean that Lexington don't have to comply with the general provisions of the Act.

It says in the link you have posted that "COSMETICS" may not be advertised as FDA Approved - this is true! But the term "Costmetic" is defined in the Act as follows:

"The term "cosmetic" means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap."

The Hairmax Lasercomb is a "DEVICE", which is defined in the Act as follows:

"The term "device" (except when used in paragraph (n) of this section and in sections 301(i), 403(f), 502(c), and 602(c)) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes."

It is obvious which category the Hairmax falls into.

 

[bubka]

a cosmetic device

which is why it can make those claims and labeling about it's designed usage, like makeup and wrinkle creams

this is not a medical device, it's a cosmetic device

 

[bubka]

KiLLuMiNaTi errr, RaMbO is back following me... :roll:

strait for the hairmax fat *** mouth:

http://www.hairmaxforum.com/forum/showthread.php?t=1878

While what you have stated is reported on numerous websites (apparently including Dr. Baumans), there is no such thing as FDA approval for cosmetic benefits.

What this means, and why it is perhaps misinterpreted, is that we are able to make ONLY cosmetic claims at this point. For example, I can tell you that the LaserComb will give you stronger, fuller, healthier looking hair, but at this point, due to the fact that we are not FDA approved for regrowth, we cannot make those claims.

Thanks,
Mike
Lexington International

thus the FDA "cleared" from the language used, and the hopeless balders see, ahhhh FDA approved somehow...

i swear some people will believe anything, like noah's arch

Def: i see what you mean, yes, i will see "little a" approved, i can go with that, just like anything else, it has to abide by the laws you listed

 

[Def]

You gotta chill, Bubka.

You're still getting caught up in semantics. Lexington have been given the green light by the FDA to advertise that the Hairmax grows hair in baldies. The FDA would not even provide Lexington with a Pre-Market Notification if it didn't - that would be misleading and deceptive and the FDA (particularly given they are on notice) would crack down on Lexington quick smart. This is more approval than any drug or device we currently use in our regimens other than Finasteride and Minoxidil (as far as I'm aware).

The reason it is not and cannot be "Approved" by the FDA is because the only devices that ARE "Approved" by the FDA are class III devices that support or sustain human life. These class III devices NEED a "Pre-Market APPROVAL" from the FDA before they can be marketed.

Class I and II devices only need the Pre-Market Notification to get the green light.

And Bubka... That quote if from March 2005! This is what Lexington currently say:

http://www.hairmaxforum.com/forum/showthread.php?t=2377

Finally - I don't really give a sh*t about any of this. I just hate when people call things "scams" when clearly they are not. I think the title of this thread is misleading and should be changed.

Def

 

[bubka]

yeah, i did notice that, but the notion that this device was just waiting for people to use it until it was FDA approved is nonsense, you could aways buy the thing regardless of this 510 submission

it's all marketing, again, why doesnt HAIRMAX say it is "FDA APPROVED"???????

 

[Def]

Of course you could always buy it. Just like any old snake oil.

However, now it has been endorsed by the FDA as promoting hair growth. Sure the FDA didn't carry out the trials themselves but I think it is a stretch to suggest that Lexington have doctored the trials and pulled one over the FDA. The FDA would spot that a mile off - in fact they sent Lexington back the first time they submitted!

So while you could buy it before the FDA Notification, it has been verified as working now BY THE FDA and people should take some assurance and peace of mind from that rather than calling it a scam constantly!

Def

 

[bubka]

anyways, i can see that we will not agree here, still though, this product is forbidden by law to say "FDA Approved"

i saw once, at least i thought, the raw data of the "trial" but now i cant seem to find it anyplace, anyone else locate it???

 

[Def]

You may be right about not being able to state "FDA Approved", however, that doesn't make any comment on the efficacy of the Hairmax Lasercomb.

Rather than a "Cosmetic Device" it is actually considered by the FDA to be a "Physical Medicine Therapeutic Device" in Class II. The links are here:

http://www.accessdata.fda.gov/scripts/c ... ID=K060305

The only thing I object to is that you seem to be suggesting that the Hairmax Lasercomb doesn't work because it isn't "FDA Approved". That's not true, and on my reading of the legislation and materials on the FDA site, it can never be "Approved" by the FDA because it is a Class II device that wouldn't go through the FDA "Pre-Market Approval" process.

Def

 

[bubka]

and here is what the FDA says a Class II device is safe to do:

http://www.accessdata.fda.gov/scripts/c ... R=890.5500

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 890 -- PHYSICAL MEDICINE DEVICES

Subpart F--Physical Medicine Therapeutic Devices
Sec. 890.5500 Infrared lamp.
(a) Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.

(b) Classification. Class II (performance standards).

 

[viperfish]

Ok Butka,
What's the difference between the FDA saying the product is "cleared" or "approved" for "Regrowth". No difference at all. It's not a drug and therefore was cleared. Hairmax would not be allowed to make claims of "regrowth" unless it was cleared by the FDA as a medical device capable of doing so.

Obviously, I see you are very stubborn and fighting with you is pointless. I agree with what def is saying to you. I just did not see the point in making it perfectly clear to you.

If you go back about ten years ago there were people, like you, that said the same thing about propecia.

I'm done.

 

[hair today gone tomorrow]

wow, what do you know? bubka is arguing with people AGAIN.

 

[bubka]

wow, what do you know? bubka is arguing with people AGAIN.

wow, it's somebody going OT to follow and obsessed about my activities here AGAIN

notice i am not the one who started this thread, just adding data to the obvious

viperfish: seriously, just because you paid $600 for a laser pointer does not mean you have to support it against all

tell me the physics, the science, of how a laser pouter at that frequency reverses hair loss, i would love to hear it???

 

[IBM]

i haven't seen a success story with laser comb. Even on hairlosshelp forum.

 

[Def]

It's a well known fact that the majority of people who do have success with their regimens don't spend time lingering around hair loss forums!

It's also a well known fact that many people don't use their regimen properly, consistently or ride the ups and downs.

I myself have had no experiences with the Hairmax or any laser comb but think they could clearly be of some benefit.

Where I have seen the real success stories with laser combs are where people use the comb (increasing circulation etc) and then apply topicals soon afterwards.

I think laser combs could, therefore, be a good adjunct to any topical regimen.

Def

 

[bubka]

Agree with DEF and Viper 100%, Bubka you are wrong as usuall..I cant beleive your allowed to post this filth :nofear:

filth? was i the one who said that "propecia is poison" thanks for trolling KiLLuMiNaTi, weren't you banned?

no, i said that this is not FDA approved (look at the title) and this device falls under such guidelines that it cannot be marketed as such

how does a light of that frequency stop hair loss???

 

[Def]

Bubka

It has been tested and "cleared" by the FDA as being able to regrow hair.

I don't know HOW the comb works specifically. I'm not sure the people at Lexington / the scientist that developed LLLT does.

Pfizer won't be able to tell you HOW minoxidil works specifically. There are various theories, but the fact is that they discovered it by accident and are still unsure as to its precise mechanism.

I reckon you should add to the title of this thread "but it has been CLEARED for regrowth".

Why are you so anti LLLT anyway?

Def

 

[Beethoven]

This is what I got. Still, I would like to see the clinical trials results published in a respectable journal and reviewed by pro Docs.

(and Rambo & HTGT : I reported your trolling of this thread. Bubka had done nothing to you here, and he was having a normal argument with viperfish and Def. You attacked him for no reason. )


Subject: FW: 07-501 cmh FW: DSMICA Email Form Response
Date: Tue, 24 Jul 2007 15:09:23 -0400
From: "Benson, Cynthia M." <cynthia> Add to Address Book Add Mobile Alert
To: X
CC: "CDRH Small Manu. Assistance" <DSMA>

Your interest in contacting the US Food and Drug Administration (FDA)
through your recent inquiry is appreciated.

The indications for use and the substantial equivalence sections of the
510(k)link you have found below contain all the information to
efficiently respond to your inquiry. The Lexington Hairmax LaserComb
has indeed been determined to be safe and effective as an aid in hair
regrowth in males. However, it can not be compared to the other
products you reference as this is a medical device and not a drug.

Hopefully, my further explanation will be helpful to you!


Cynthia Benson
Office of Communication, Education
and Radiation Programs
Center for Devices and Radiological Health
U.S. Food and Drug Administration
1-800-638-2041, ext. 109

-----Original Message-----
From: [email protected] [mailto:[email protected]]
Sent: Monday, July 23, 2007 2:58 PM
To: CDRH Small Manu. Assistance
Subject: DSMICA Email Form Response


Name: X
Phone Number:
Fax Number:
Email Address: X
Mailing Address:

Questions/Comments:

My question is regarding Lexington Hairmax Lasercomb.
This device had received your 510(k) approval on 18 January 2007,
according to your web site:
http://www.fda.gov/cdrh/pdf6/K060305.pdf

The meaning of this approval is a bit vague and there are many debates
about it in hairloss forums.
Could you please clarify to me the following: Is this device has been
approved as cosemtically safe to use, or is actually approved as
medically efficient for hair regrowth? (in the same manner as propecia
and rogaine are medically proven and approved by the FDA for treatment
of Androgenetic Alopecia).

Thanks in advance,

X