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Copyright 1998-2001. All rights reserved.

EpiTouch Alexandrite laser

Sharplan's EpiTouch Alex was cleared to market in the U.S. on December 4, 1997. Like many hair removal lasers, EpiTouch alexandrite lasers were originally designed to treat vascular lesions and were later submitted for hair removal. The target depth for vascular lesions and hair removal are very different. Vascular lesions are rarely more than 2 millimeters deep, while even moderately coarse hairs start at depths of 2 mm, with typical male facial hair often going twice as deep as that. Light intesity falls off sharply with each millimeter. Also, the hairs are at highly variable depths as opposed the to relatively even depths found in vascular lesions. Since no modifications have been made to the device since the vascular lesion patent, the target depth for hair removal may be inadequate.

Sharplan claims the alexandrite system is faster than their earlier EpiTouch ruby. Beyond that, there's little information on this product.

FDA 510(k) data

510(k) Number:  K973354

Device Name:  SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)

Applicant:  SHARPLAN LASERS, INC. 33 PLAN WAY WARWICK,  RI  02886

Contact:  GEORGE J HATTUB

Date Received:  09/05/97

Decision Date:  12/04/97

Decision:  Substantially Equivalent

Predicate devices: Cynosure's PhotoGenica and Sharplan's alexandrite for vascular lesions (K971874). Sharplan states, "No significant differences exist" between this product and the two mentioned as predicates.

Studies: "Clinical data on 40 subjects was presented." That's all they say. A press release claimed the clearance was based on a 6- to 9-month follow-up of a clinical study, but they didn't bother with any important details there, either.

Intended use as cleared by FDA: "Removal of unwanted dark body hair."

Client results

If you are or plan to be undergoing treatment, please contact me so I can track your results.

Client 1: T_____

T_____ writes from Paris and began neck treatment at the end of 1998, with hopes of doing face work after assessing the results. T_____ has promised to keep me informed of all progress.

Why try it ?

My beard is very difficult to shave. I have to use both an electric shaver and a twin blade shaver to be shaved properly. I first use the electric shaver and then the twin blade one. Using only the twin blade shaver is a very painful process. My light complexion and black beard give me a permanent beard shadow, even immediately after shave.

Why laser ?

I am aware that laser is still in its experimental phase and that results are not guaranteed. On the other hand, I have a light complexion and a black beard, which are known to produce the best results with lasers. Electrolysis is too heavy a process for me. I am willing to risk some money on laser. My only unresolved concern is potential damage to the skin. Strategy: go in small steps: test on a small area , then try 3 treatments in neck region, then wait a year and see what happens, then depending on the results may decide to go for the whole face.

Laser device, center and cost information

After some market study, found an acceptable price: 2400 FF ($400) for 3 treatments in neck region. Laser device is an EpiTouch Alexandrite Model 5100. Center is located in Paris and is carried out by doctors. They have been willing to talk openly about the technology, its limits and unknowns. Most other centers I called or visited were reluctant to provide me with information. Some centers would not even tell which device they are using !

Friday, November 6, 1998. Test.

Performed test in small area in the lower part of the neck. Laser power at 15kj (?). Mildly painful. Some redness afterwards. Took about 3 weeks for redness to disappear. Doctor says redness is not related to laser treatment but was there before (true) and laser may have made it stronger. Hair in the treated area falls down after 10-15 days.About 90% of hair has disappeared in the treated region.

Friday, December 4, 1998. First treatment.

Neck region (all neck up to under jawbone line). Applied EMLA cream 1h before treatment (too short ?). Treatment mildly painful in neck region, very painful when getting closer to jawbone line. Treatment lasted less than 10 minutes. Laser power at ??. Some redness afterwards, no swelling. Applied Biafine cream at regular intervals during weekend. Redness completely disappeared in 3 days. Hair in the treated region is difficult to shave the week after, it looks like it is too "soft" for the shaver to efficiently grab and remove it.

Saturday, December 12, 1998

Hair in the treated region can be removed by hand quite easily.

B___'s experiences

[B___ is a genetic woman. Keep in mind her hair removal requirements were likely far less than yours.  --A]

My skin is very pale to pale (1 or 2). As I now live in England (I was born and raised in California, then moved to AZ before going to England), my skin has become quite pale. My facial hair colors vary from quite dark brown to blonde, with an assortment of dark and light red added in just to make things complicated. If I wasn't 31 years old I might be insulted that you asked me how many grey hairs I have. I'm not, and I have none. No horemones (I've been off the pill for about 4 years), thought twice I was tested for excess testocerone and twice I came within normal parameters for a woman my age. I guess I've just descended from a family of apes. I had some electrolysis done when I was 19, but the pain and embarassment became intolerable. I was heading for a career in acting and singing (and made it, too!) and so it was very inconvenient for me to have facial hair.

Recently I decided that after years of feeling unfeminine, of having to deal with a "shadow' (my friends who I've told had NO idea that I shaved my facxe every day at all), that I would try to get rid of this sandpaper on my face once and for all. I was really encouraged to read about laser hair removal. It was a ray of hope for me. So I grabbed copies of all the health and beauty magazines I could find in London where I live. I called quite a few different places and asked if I could receive information and have a test patch done. If they tried to push me into ANYTHING on the spot I tucked my hairy tail between my legs, ran, and never looked back. It was a good tactic; I narrowed it down to four places where I intended to have test patches done.

First I went to a Harley street cosmetic surgery place in London (late November, 1998) . They were very understanding, but during the initial free consultation they tried to push buying a course of 6-8 sessions (at a reduced price, of course) of treatment with their "Cool Touch" Alexandertie laser (I'm unsure who makes it, but I suspect it's a Shaplan. I'll check when I get back.). I believe that "Cool Touch" refers to the machine that blows cold air onto your skin as they treat you with the laser. One week and approximently $80 dollars (fifty pounds sterling/UK) later, I found myself having my first test patch done on my chin and the side of my face. The plesant, but somewhat confused as I later found out, nurse started the test area at 12 k jules (I think). Not EVEN enough for me. She went up to 25 kjules, and then told me they would have to treat me at at least 28-30 if I decided to do the full course. The mild pain was very tolerable, and I have a VERY low pain threshold (I will be the Epidural queen if I ever have a baby!!). After the treatment she sat me down with an ice pack and some aloe vera gel just to make sure I didn't turn purple or start oozing silly putty or whatever. As I was sitting there, she cheerfully informed me that I could not shave the area for a week, but I was to exfoliate every day (contrary to what I'd been told inthe consultation). It crossed my mind that this was just a tad contradictory. I was also a little upset that no one had mentioned this when I had the consultation or when I booked the test patch. Never mind. No one noticed when I hosted a friend's wedding reception two days later (except for me and my ever-supportive husband). I had little or no redness in the area, and no swelling. Though by day five I had to shave it off because I had to perform that night. And I felt absolutely AWFUL with this dark hair on my face!!! Within about 12 days, the area was bald as a ping pong ball and I was elated. I was just concerned about how commercial they were. I also didn't like the idea that I would be running around for a week with stubble every time I had a treatment! Can you say "career impediment"?

[On that page, B___ also describes her unpleasant test patch experiences with EpiLight.]

Test patch 3 was done a week after #2 at the Royal Free Hospital in London by a nurse with another Alexanderite laseer. I don't know the brand name, but she thought they had the only one in the UK. To me it looked like the same machine they used at the first place. Certainly the k jules were measured in the same way. During the initial consultation she spent an hour or more answering all my questions, bringing up her own doubts, etc. She also showed me the areas on her body where she had been treated (successfully, I might add). No sales pitches, she was happy to let me go if wanted to, and was very knowledgeable. She did four test patches on each area I requested. The first was always at 15kjules, and the last no higher than 25. She waited to see how my skin responded after each energy level, then took careful notes of how I responded. I had had very slight redness and swelling (like a little goosebump) around some of the follicles.She actually explained that that was what she was looking for (a "goosebump" reaction), and that my body responded best to the medium high range of kjules, depending on the area of treatment. My chin worked best at 18, while my neck was about 23 or so. The hair fell out 12 days later and is still clear.I later had my tummy done along the "V-line" at 24 on the left half, and 28 on the right. The left side is still clear from the treatment done in mid December. The right side is only partially clear, but she said she wouldn't charge me to re-do it if it didn't work. The facial test patch cost me approx. $74 (40 pounds sterling/UK). Subsequent treatments would cost about $740 (400 pounds sterling/UK), but she was very casual about the cost. This was because all the money was going to research for excema, birthmark/Port Wine Stain removal, and psoraisis. In fact, she has not charged me for test patches done on my tummy, arms, or the back of my neck. And she was just a nice person! She also told me that I would only have to do one or two treatments. I am still skeptical about this estimate. The pain was very minimal (remember, I'm a wimp), and no more painful than the "Cool Touch" laser that promised to ease any pain with what's tantemount to air conditioning. The nurse at the Royal Free also said I could shave the next morning, that I should just wear sunscreen and be kind to my skin. When I related the "don't-shave-for-a-week-but-exfoliate-every-day" tale, she rolled her eyes and asked what the difference was. All in all, I was very satisfied with this last treatment. But time will tell best.

Contact information

Mail, phone, email

Sharplan Lasers, Inc.

One Pearl Court,

Allendale, NJ 07401, U.S.A.

Phone: 201-327-1666 or 800-394-2000

Fax: 201-445-4048

Reminder:

If you seek permanent hair removal and cannot afford to risk your time, money, or complexion on unproven methods, invest in the only proven permanent method available today: electrolysis.