Where Are The HairMax Lasercomb Studies?

[someone uk]

i find the whole concept of laser treatment insulting to my intelligence
i mean for one thing the hairmax comb is priced disproportionately for a stick with 5 laser diodes in it
no one has ever justified why the light has to be "laser light", and even that only has 2 reasons, neither can be justified for this reason

laser comb is a scam with an FDA approval

[blowmeup]

It’s FDA cleared which is a big difference.

[Andyman79]

It’s FDA cleared which is a big difference.

Am I right in thinking that to gain both FDA Clearance and Approval you would require a study to show safety and efficacy but Approval is not given without a clinical study to back the study up?

I would be interested to know the actual definitions if anyone can help.

[KeepTheHair]

Andyman

According to my understanding I think that FDA cleared means that it has been cleared for SAFETY.

FDA Approval is it has been approved to DO SOMETHING like prevent hairloss and regrow hair.


The HairMax LaserComb has been approved and cleared I think. I was 100% sure I was getting it until I read the varied opinions in this thread...


I have seen good reviews..it's FDA approved and seems like a good product...

Are you guys really that sure that it does not work? I really want to try it but I mean... it's insanely expensive in time and money.

Thanks

[Winston]

What are 510(k) Clearance and Premarket Approval?

Jason Smith
Stephen Barrett, M.D.

All manufacturers who wish to market devices in the United States are required to register with the FDA and are subject to periodic audits. This article describes the marketing pathways they can choose.
Device Classification

The 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act created three categories of medical devices, based on the level of risk:

Class I: Generally, these are simple devices with minimal risk to the user. Almost all of these devices are exempt from FDA clearance or approval. Examples: enemas, crutches, elastic bandages, bedpans.

Class II: These devices pose a moderate level of risk to the user. Almost all of these devices require a regulatory submission before they can be legally marketed. As a rule, class II devices require 510(k) submissions. Examples: condoms, intravenous administration sets, sutures, inflatable blood pressure cuffs.

Class III: These devices pose a serious level of risk to the user, mostly because they are implants or sustain life. All of these devices require a regulatory submission before they can be legally marketed. As a rule, class III devices require a PMA (Premarket Approval) submission (described in further detail below). Examples: implantable pacemakers, blood vessel stents, breast implants.

Registration is required regardless of the classification. The method chosen depends on what the manufacturer wishes to claim and whether similar devices have been cleared or approved.

510(k) Clearance

The purpose of a 510(k) submission is to demonstrate that a device is “substantially equivalent” to a predicate device (one that has been cleared by the FDA or marketed before 1976). The 510(k) submitter compares and contrasts the subject and predicate devices, explaining why any differences between them should be acceptable. Human data are usually not required for a 510(k) submission; this decision is made at the discretion of the FDA. Laboratory testing is almost always a requirement. Depending on the type of 510(k), the law gives the FDA either 30 or 90 days to clear the device, ask questions, or reject the application.

Manufacturers may also submit a 510(k) if they alter their device. Not all changes require a 510(k) submission. In general, changes to a device’s intended use, contraindications, or basic operation require a new 510(k) clearance. Changes to blood-contacting materials, sterilization method, or performance specifications may also require a new 510(k).

The FDA does not “approve” 510(k) submissions. It “clears” them. It is not legal to advertise a 510(k) cleared device as “FDA-approved.”

Premarket Approval (PMA)

A PMA submission is used to demonstrate to the FDA that a new or modified device is safe and effective. This standard is higher than is required for 510(k) submissions. Human use data from a formal clinical study is almost always required in addition to laboratory studies. The FDA is required to approve, question, or reject the application within 180 days. Changes to a PMA-approved device may require a PMA supplement or even a new PMA. Manufacturers have far less leeway in modifying PMA devices than they do for changes to 510(k) devices. PMA devices can be legally advertised as “PMA-approved” or “FDA-approved.”

Checking Documents

Submissions for 510(k) and PMA are public documents except for portions that contain trade secrets, confidential commercial/financial information, or information that is personal and private (such as patient records from clinical trials). For both types of submissions, the FDA maintains searchable online databases that contain only a small amount of information. Additional documents that are releasable can be accessed through a Freedom of Information (FOI) request. The first time an FOI request is made for a submission, the FDA notifies the original submitter, who is then allowed to delete proprietary and personal information.

If searching an online database, note the current manufacturer or distributor may not be listed as the submitter in the database. This happens because the FDA database is not updated when ownership of a 510(k) or PMA is sold or transferred between business entities. So submitter information refers only to the company that made the submission. Therefore, if company A gets PMA 123 approved for their product, but later sells that product to company B, the PMA database for number 123 will list company A as the submitter, even though company A might not have made the product for many years. Also, foreign companies can have domestic firms make submissions, and consultants who write submissions might be listed as submitters.

Defrauding the FDA

Manufactures of quack devices sometimes seek clearance without telling the FDA that their device will be used differently from the predicate device. For example, several devices said to measure skin resistance are accompanied by software that fabricate diagnoses and recommends products. This set-up is illegal because the basic device has not been cleared for such purposes. In addition, the FDA would consider the software to be a separate device—very likely in Class III—that would require premarket approval.

Mr. Smith is employed in the medical device industry and has been writing regulatory submissions for over 14 years.

This article was posted on April 12, 2008.
http://www.devicewatch.org/reg/reg.shtml

[KeepTheHair]

You mind summarizing?

[Fixed by 35]

Please don't waste you money on old tat like that. Consider the following:

1) The reviews on Amazon.com are absolutely appalling.

2) To be approved, it needs to work. It doesn't need to work that well. Even their own before and after photos are disappointing!

3) Laser therapy might have a future in combination with the regeneration topicals (see Follica) but on their own they are useless. I guess it may be possible the combination of a laser comb and minoxidil is effective, but I doubt it.

[KeepTheHair]

Seriously, if it helps to maintain what I have, or slightly improves what I have as a 20 year old. Then it's more than worth it.

Losing a bit more hair is a big difference compared to gaining a slight bit of hair. At 20 I think this is a good method to try and halt this process until something better comes out or so in the future.

[KeepTheHair]

You guys have it wrong. The product is FDA approved for regrowing hair/preventing further hair loss.

It does work. Enough people and doctors confirm this.


Even if only slightly effective I am definitely going to add it to my arsenal.

[Winston]

Sorry son, it’s you who are wrong. There is no FDA approved laser for hair loss. It doesn't exist. The FDA clears many useless devises.