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Copyright 1998-2001. All rights reserved.

 


EpiTouch ruby laser

Laser Industries (also known as Sharplan) was cleared to market the EpiTouch in the U.S. on August 27, 1997. There has been little information made available about their EpiTouch ruby system. They claim their procedure does not need a cooling handpiece because they use a transparent gel. Since they were cleared, ESC bought Laser Industries.

Basically, they've let other lasers do all the work and are a me-too brand with a weak market presence.

FDA 510(k) data

The full name on their 510(k) is the Sharplan EpiTouch Model 5000 modified ruby laser system. The modification is a fiber delivery system. Its intended use is "for the removal of unwanted dark body hair."

Predicate device: Chromos 694. "No significant differences exist." Therefore, no clinical data was presented with their application. How convenient.

  • 510(k) Number:  K972099
  • Device Name:  SHARPLAN EPITOUCH RUBY LASER SYSTEM
  • Applicant:  SHARPLAN LASERS, INC  33 PLAN WAY  WARWICK,  RI  02886
  • Contact:  GEORGE J HATTUB
  • Date Received:  06/04/97
  • Decision Date:  08/27/97
  • Decision:  Substantially Equivalent

The 510(k) warns that information provided does not mean "the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill."

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Clinical data

Again, very little out there. A 1997 trade article discussed a clinical trial underway in Santa Barbara, CA under Greg Keller, MD. Fifty patients with skin types I to III get three facial treatments at two-week intervals. Keller states, "We follow patients for a year, but the answers come fairly quickly because the growth cycle is so quick."

Ted sent along this Epitouch medical abstract he found on Medline:

Dermatological Surgery, 1997 Sep; 23(9): 737-739

Laser-assisted hair removal by selective photothermolysis. Preliminary results. Lask G, Elman M, Slatkine M, Waldman A, Rozenberg Z.  Division of Dermatology, UCLA Medical Center, USA.

BACKGROUND: Laser-assisted hair removal with the long pulsed ruby laser is a promising new technique based on selectively targeting melanin in hair follicles.

OBJECTIVE: The purpose of this study was to evaluate the efficacy and safety of the long pulsed ruby laser (EpiTouch) for hair removal.

METHODS: The Epitouch laser was used for hair removal of the arms of 20 patients. The areas were evaluated immediately post-treatment, and at 1, 4, 8, and 12 weeks, for efficacy and complications.

RESULTS: Postoperative results showed 40-80% regrowth after 12 weeks.

There you have it. Same as everyone else's.

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Bad results from a flawed study

As if these results weren't bad enough, two prominent physicians published a medical paper in July, 1998 Archives of Dermatology ripping Lask's study. Whitney Tope, M.D. and Maria Hordinsky, M.D. are experts in the field of hair loss and have written extensively on the topic in medical literature. Their article is titled "A Hair's Breadth Closer?" The title's question mark is followed by some serious questions about the methodology and even the validity of clinical laser studies done to date. They specifically criticize the Lask study for:

inadequate hair growth evaluation methods

an absence of histopathologic data

little statistical analysis

all too brief follow-up

I agree 100% with Tope and Hordnisky.

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Client results

J__is a full-time MTF TS who has written a detailed account of her experiences with SoftLight. When that was inadequate, she switched to EpiTouch.

She wrote to me in December, 1997, "I had no conventional electrolysis prior to laser. Since then I have had probably no more than 5 or 6 hours both before and during the EpiTouch treatments." She had treatments on 7/22/97 and 11/3/97, and each cost "about $450 - $500."  

She bought a block of SoftLight treatment which was transferred to the EpiTouch: "I paid for the initial treatment with the Softlight and then bought four more treatments at he package price for five treatments minus the cost of the first treatment. Each session was for treatment of the entire face and neck regardless of time taken."

To conceal hair between treatments, J__ says, "I shave daily. At this point I can pass pretty well if I skip a day and use makeup."

Treatment was much more bearable than the horrifying 6-hour SoftLight pre-waxing she described previously: "For the first Softlight treatment, when my beard was waxed I received some local anesthetic for part of the treatment of the upper lip and chin. I have had nothing since then. The Epitouch feels more like little individual droplets of hot oil falling on the skin. Each individual burst of the laser is like a drop.

Like many people who avoid electrolysis, J__'s primary reason was pain, followed by the hope of saving money and time in the long run: "I was looking for the fastest method to get results which required the least amount of total hours and hopefully the least chance of scarring."

"As far as the face goes, for dark hair it is definitely capable of killing follicles and may just take longer because the hair is larger and thicker. As far as light-colored hair goes, I don't know if it is having any effect."

I wrote a follow-up to J__on December 5, 1998, and she replied the next day:

I have nothing useful for you on laser electrolysis at this time as I have been concentrating on needle electolysis for my face for this past year. --

The typical laser pattern again: optimism that fades into disillusion when poor results occur.

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Contact information

Sharplan's EpiTouch webpage states: "While the areas treated will remain clear for some time after, eventually those follicles that were in the dormant (telogen) stage will regrow."

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.