Palomar home use laser FDA clearance text

http://www.sec.gov/Archives/edgar/data/881695/000088169506000034/ex992.htm

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

  	Food and Drug Administration
  	9200 Corporate Boulevard
  	Rockville MD 20850

Palomar Medical Technologies, Inc.
c/o Ms. Sharon Timberlake, RAC, CCRA
Director of Regulatory Affairs
82 Cambridge Street
Burlington, Massachusetts 01803

Re: K060839
Trade/Device Name: ABC Hair Removal System
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: II
Product Code: GEX
Dated: July 24, 2006
Received: July 25, 2006

Dear Ms. Timberlake:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Page 2 – Ms. Sharon Timberlake

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, “Misbranding by reference to premarket notification” (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
 

Mark N. Melkerson
Director
Division of General, Restorative
  and Neurological Devices
Office of Device Evaluation
Center for Devices and
  Radiological Health

Enclosure

Indications for Use

510(k) Number (if known): K060839

Device Name: ABC Hair Removal System

Indications for Use:

The ABC Hair Removal System is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
 
510(k) Number     12060835    

Prescription Use _____ OR Over-The-Counter Use X
(Per 21 CFR 801.109)
(Optional Format 1-2-96)

PALOMAR MEDICAL TECHONOLGIES, INC.
CONFIDENTIAL
ABC HAIR REMOVAL SYSTEM 510(K)

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RPT-UPDATE 2-Palomar shares up as FDA OKs OTC laser device
Mon Dec 11, 2006 12:23pm ET137
NEW YORK, Dec 11 (Reuters) - Palomar Medical Technologies Inc. (PMTI.O: Quote, Profile , Research) shares were up nearly 11 percent in midday trading after the company said it has received regulatory approval to market its light-based hair removal device over the counter.

Palomar, which develops light-based systems for cosmetic treatments, said the clearance by the U.S. Food and Drug Administration allows it to sell the product directly to consumers without a prescription.

Initially developed by Palomar, the device was completed after a decade of research with Gillette Co., part of Procter & Gamble Co. (PG.N: Quote, Profile , Research), Palomar said in a statement.

Palomar said in September that within 30 days of receiving approval from the U.S. Food and Drug Administration, Gillette would pay it a $2.5 million development completion payment.

Gillette is the world’s leading razor maker. An in-home, and more permanent, hair removal solution could have a negative effect on razor sales.

Palomar’s home-use device is designed as an alternative to laser hair removal procedures normally performed by doctors and trained cosmetic professionals in clinics, spas and salons.

Shares of the company traded as high as $58.10 earlier on Monday, their highest price in nearly a decade, but the stock lost some ground to $55.34 a share, up $5.38, or 10.8 percent, around noon on Nasdaq.

how much would this product cost?

Price point isn’t set yet. Here’s its intended use:

“intended for adjunctive use with shaving for hair removal sustained with periodic treatments.”

In other words, it’s a shaving supplement, not replacement, and is probably too low power to cause permanent hair removal. Still, this could be a good option for some consumers.

This has been in development for many years. Stay tuned.

Actually, this is not the first such product of this type. Six years ago, Radiency came out with a low powered IPL (8 joules max) that they sold as a means to provide long term hair suppression. In other words, it didn’t kill the hair but it would potentially give you a hair free period. It pretty much didn’t do anything. The big deal was probably the price point which was quite expensive.

My understanding is that this is a low powered laser device that will hopefully decrease hair growth. My guess is that it won’t work. I think Palomar got into this because Gillette dangled a bunch of money in front of them. Whether they believe it will work is another story. It will be interesting to see how this plays out.

The world is full of technologies that purport to make hair a thing of the past, most of them fail. We’ll see.

The Radiancy device was prescription only, but this is cleared for over-the-counter sale.

I would definatley try it.

The Radiancy device was prescription only, but this is cleared for over-the-counter sale.

Please don’t quote me on this as I am relying on my memory. But I think because the Radiancy device was only 8 joules and not a laser but an IPL, that it fell in the Class III or Class II device category (not Class IV) and as such did not have to be sold under a prescription. Which meant that it could be sold to anyone. Or maybe they were looking to sell it to spas. That seems to ring a bell in my mind.

And I remember discussing this very issue with the national sales manager for Radiancy who was telling me how they were going to market this to non-physicians for home use. At that point, it was clearly not prescription only in their mind.

And we may be confusing several devices. Because I believe that Radiancy had several devices for sale over the years. They are still in business, though I am not sure what they are currently selling.

Bottom line is that a low powered device didn’t succeed very well in the market. And wasn’t very effective.

I’ve been treated with the IPL Palomar Este Lux and it’s a pretty good device. I know you are all looking for long term answers, but I just used to to make the hair shed for the time being. If this device is anything like it, I will be so happy. Most of the time the missed hairs on my shoulders are because my tech sucks and doesn’t take the time to get them all. What is the joules on this machine going to be like?

I’ve been treated with the IPL Palomar Este Lux and it’s a pretty good device. I know you are all looking for long term answers, but I just used to to make the hair shed for the time being. If this device is anything like it, I will be so happy. Most of the time the missed hairs on my shoulders are because my tech sucks and doesn’t take the time to get them all. What is the joules on this machine going to be like?

It is absolutely nothing like that, except in name only. This is like comparing a laser pointer with a 10,000 watt searchlight. They both can be used to point.

Of course, my guess is that the laser pointer is probably going to provide more value than the home laser hair removal device. We’ll see.

any new information on this product?

If it looks to good to be true, it probably is.

Question: is this device intended for women?

Features of the home laser removal device
a. It is an at home device that enables women to do their hair removal work at their homes.
b. It would require treatment once or twice a week, to maintain hairlessness.
c. Device should not be used on face or scalp.
e. Experts are not too sure at this time if this device will eliminate the need for shaving permanently.
f. The laser used in the home hair removal device is not as intense as a commercially available hair removal treatments.
g. The price and availability of the home hair removal device is not known at this time.

Features of the home laser removal device
e. Experts are not too sure at this time if this device will eliminate the need for shaving permanently.
f. The laser used in the home hair removal device is not as intense as a commercially available hair removal treatments.
g. The price and availability of the home hair removal device is not known at this time.

Regarding f: Naturally, otherwise burns would occur and Gillette would be sued out of existence.

Regarding e: Given f above and how hard it is to permanently remove hair with powerful lasers, this is quite doubtful. I would say impossible, but one never knows. After all "hope springs eternally from the human . . . " which is what the people who sell this kind of stuff count on.

Regarding g: The real question is whether Gillette which makes a big chunk of money from razor sales will actually release a product that may not work, or at most work minimally, but that may cut into their razor sales. They may bury this product, never to see the light of day.

In simple words: it’s useless for those who look for a serious solution for excess hair. Those who don’t have excess hair are just not interested in this product, I would think.

Any updates to this?