DepiCool UK – Blog

ON JULY 7, 1997, THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) COMPLETED THEIR REVIEW OF THE EPILIGHT HAIR REMOVAL SYSTEM. BASED UPON THE TECHNICAL INFORMATION AND CLINICAL DATA PROVIDED, THE FDA GRANTED CLEARANCE FOR THE COMMERCIALIZATION IN THE USA OF THE EPILIGHT HAIR REMOVAL SYSTEM FOR THE REMOVAL OF UNWANTED BODY HAIR.

The following is a news release that describes the FDA Approval of Epilight in detail:

Clearance Received from FDA to Market Epilight Hair Removal
System

Needham, MA July 21, 1997. ESC Medical Systems announced it received clearance from the U.S. Food and Drug Administration to market the Epilight Hair Removal System, a safe noninvasive treatment for the removal of unwanted hair.

The EpiLight Hair Removal System uses patented intense light energy to effectively eliminate undesired hair of all colors from all parts of the body on nearly all skin types while reducing potential side effects. Known as photo-epilation, the EpiLight’s unique method enables the pulsed light to penetrate deeply enough and with sufficient energy to damage the hair follicles without harming the surrounding skin tissue. This approach provides the physician and patient with important clinical benefits over existing hair removal methods like electrolysis, waxing, depilatories or laser procedures.

For the patient, hair removal using the EpiLight System means effective results, faster treatment time and minimal discomfort. For the physician, the device’s innovative technology allows him/her to adjust and customize treatment parameters to the particular body area, specific hair color and exact skin type of the patient. This capability is largely due to the EpiLight’s unique capacity to select a wide range of treatment parameters such as spectral output, pulse structure and pulse duration, which is based on the same patented technology as the successful PhotoDerm® VL/PL for the treatment of vascular and pigmented lesions.

“In one treatment with the EpiLight, we have obtained excellent immediate results on a large number of hairs with minimal side effects,” says Michael Gold, M.D., who conducted clinical trial studies on the EpiLight. “Many of my patients have spent a lifetime battling unwanted hair growth and have unsuccessfully tried other hair removal methods, such as electrolysis and lasers. The EpiLight gives them a renewed hope,” notes Dr. Gold, who is a cosmetic dermatologic surgeon in Nashville, TN.

The initial FDA clinical study examined more than 100 female and male patients who were treated once to remove unwanted hair on the chin, mustache, neck, trunk, bikini line, arm and leg. More than 200 anatomical sites were monitored for a period of 3 months following treatment. A transparent cooling gel was applied to the treated area prior to light exposure, and no local anesthesia was administered. Study results showed EpiLight achieved an average clearance of 52% for all hair colors, anatomical sites and skin pigmentation types at 3 months after a single treatment.

Owing to its non-laser principles of operation, the EpiLight Hair Removal System overcomes several critical limitations inherent in laser systems. Distinct from lasers which are set at a fixed wavelength, the EpiLight uses a wide spectrum of wavelengths and pulse widths. In particular, it offers an adjustable broad wavelength range, unique light pulse capabilities, and a large spot size. Also, the device’s larger spot size means it can cover more area faster and in fewer treatment sessions. This unrivaled design provides optimum versatility and maximum flexibility to remove all hair colors from all body parts on most skin types quickly and efficiently.

“At one year follow-up with only several treatment sessions, we have achieved safe and effective hair removal with minimal discomfort and minimal recovery time,” states Drs. Margaret A. and Robert A. Weiss, associate professors of dermatology at John Hopkins University in Baltimore. “Before the EpiLight, removal of dense hair from huge areas, like the back, was impossible. Now, the extremely large footprint of each EpiLight pulse allows rapid treatment of large body surfaces. We are delighted to be able to offer our patients an exciting new solution for unwanted body hair.”

The scientific foundation underlying the EpiLight Hair Removal System is the principle of selective photothermolysis in which EpiLight’s intense pulsed light is converted into heat when it is absorbed by melanin. Melanin is the most significant chromophore in hair which absorbs light. When light is absorbed in the hair follicle, hair shaft or the bulb, it raises their temperature. Once the temperature reaches a high enough level, the targeted hair structures are destroyed and hair regrowth is impaired.

Epilight Hair Removal System is manufactured by ESC Medical Systems Ltd. of Yokneam, Israel. Marketing and clinical support for the U.S. market are provided by ESC Medical Systems Inc., a wholly owned subsidiary in Needham, MA. At present, there are more than 100 Epilight Systems installed in clinics worldwide.

(ESC Medical System’s consumer hotline: 1-888-HAIR-011)

Device Name: Epilight Hair Removal System

Indications for Use: The Epilight Hair Removal System is used for the removal of unwanted hair.

FDA Approves Intense Pulsed Light Technology For Permanent Hair Reduction

February 2, 2000 (Needham, MA) – ESC Medical Systems today announced that the US Food and Drug Administration (FDA) has determined that its proprietary Intense Pulsed Light (IPL) technology for hair removal can be marketed to provide “permanent hair reduction.” This new claim is based on strong scientific studies with patients in multiple clinics and a carefully constructed statistical analysis.

Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. The number of regrowing hairs must be stable over a time greater than the duration of the complete growth cycle of hair follicles, which varies from 4-12 months depending on body site. “IPL photoepilation technology is the ONLY treatment of its kind to demonstrate such high clearance rates for hair removal,” said Neil Sadick, MD, Clinical Associate Professor of Dermatology at New York Hospital-Cornell Medical Center, New York, and co-investigator of the study. “Unlike other laser systems, IPL therapy appears to produce a genuine destruction of hair follicles, rather than temporarily disabling them,” added co-investigator Michael Gold, MD a Cosmetic Dermatologic Surgeon in Nashville, TN.

Two separate studies were conducted to support this claim. One measured the effect of IPL hair removal after a single treatment; the second after two to six treatments. Results showed an average clearance rate of greater than 76% permanent hair reduction at 12 months and 84% at 24 months following the treatment regimen.

“The FDA determination for out IPL hair removal technology is very exciting and demonstrates the Company’s commitment to breakthrough research and clinical solutions to raise the standard of patient care,” said Louis Scafuri, CEO of the Americas for ESC Medical Systems. “We’re confident that our current and new IPL family of products will continue to drive revenue growth and keep us and our customers competitive.”

IPL hair removal technology provides a gentle, noninvasive treatment that is used to eliminate the full range of unwanted hair problems. Bursts of intense light energy, heat and damage the hair follicle, causing the treated hair to fall out while sparing the healthy surrounding tissue. Treatment parameters can be customized according to a person’s skin color, hair density and specific anatomical site, no matter how deep the hair follicles reside.

ESC Medical Systems develops, manufactures and markets medical devices utilizing state-of-the art proprietary intense pulsed light source and laser technology. Its systems are used in a variety of surgical and medical applications, including ENT, OB/GYN and neurosurgery, as well as for the noninvasive treatment of varicose veins and other benign vascular lesions, pigmented lesions, hair removal and skin rejuvenation.

RELEASED February 2, 2000

FDA Approves Intense Pulsed Light Technology For Hair Removal of Darkest Skin Types (TYPE VI)

February 29, 2000 (Needham, MA) – ESC Medical Systems today announced that the US Food and Drug Administration (FDA) has cleared its proprietary Intense Pulsed Light (IPL) technology for hair removal of skin type VI, or the darkest skin types, including black skin. Now, for the first time ever, black-skinned individuals have a treatment solution available to them for removing unwanted hair. ESC’s IPL hair removal systems are the only devices that have been proven safe and effective on black skin.

Yacha Sutton, CEO of ESC Medical said, “This represents a major breakthrough and is the second FDA clearance received for our IPL technology in less than a month. On February 2, we announced that the FDA had cleared the technology for a claim of permanent hair reduction on all body sites, which offers a significant advantage over most other hair removal methods. We are pleased to be recognized once again for our leadership in light based technology with this gold standard product.

Hair removal in the U.S. alone is a multi-billion dollar market. This new clearance allows ESC to offer treatment to another market segment consisting of 13% of the U.S. population.

“Until now, dark-complexioned patients had few options for the removal of unwanted hair and the results were at best temporary.” Said Franklin Johnson, MD, a lead investigator in the clinical study of the IPL system on skin type VI. “Now, with the new longer wavelength, we can apply the deeper effects of the technology for hair removal, while bypassing the epidermal melanin present in dark-skinned individuals,” explained Dr. Johnson, who is a general surgeon affiliated with Winthrop University Hospital in Mineola, NY.

Results of the multi-center clinical study to evaluate the efficacy of one IPL treatment on very dark-skinned patients were comparable to average hair clearance rates reported in other studies on lighter skin types.

“We are extremely please to be the first in the industry to provide a new segment of the population access to this clinical advance in hair removal treatment,” said Louis Scafuri, CEO of the Americas for ESC Medical Systems. “It represents the cornerstone of our growth strategy and demonstrates our leadership position in the marketplace.”

ESC Medical Systems develops, manufactures and markets medical devices utilizing state-of-the art proprietary intense pulsed light source and laser technology. Its systems are used in a variety of surgical and medical applications, including ENT, OB/GYN and neurosurgery, as well as for the noninvasive treatment of varicose veins and other benign vascular lesions, pigmented lesions, hair removal and skin rejuvenation.

RELEASED February 29, 2000

**Article taken from www.hairtodaygontomorrow.com, accessed on 16/04/08**