ELOS system (IPL+RF)


#1

Have anyone more inbformation (Andrea?) about the ELOS sytem (aurora). It`s an Israel company, look at there website: www.syneron.com


#2

This device was cleared in FDA docket K021149 on 9 July 2002: “The Aurora DS is indicated for non-invasive hair removal.”

Below is a press release. Several well-known laser researchers are said to be involved in investigations of this device.

</font><blockquote><font size=“1” face=“Verdana, Helvetica, sans-serif”>quote:</font><hr /><font size=“2” face=“Verdana, Helvetica, sans-serif”>

NEW! Aurora DS™ ELOS technology receives
FDA clearance for hair removal

Yokneam, Israel, and Toronto, Canada, July 16, 2002 - Syneron Medical Ltd., and its North American subsidiary Syneron Inc., today announced that Syneron has received US Food & Drug Administration (FDA) clearance to market the Aurora DS™ system for non-invasive hair removal. Aurora DS received its CE mark in December of 2001 and is already cleared for sales in Europe, Canada and other parts of the world. The system has already established a strong acceptance rate among physicians and patients outside of the US.

The Aurora DS utilizes Syneron’s proprietary ELOS™ (Electro-Optic Synergy System) technology to combine optical energy and electrical energy (conducted RF). It provides the basis for highly efficient, safe and cost-effective systems that enable physicians to offer new and improved services to their patients.

The FDA clearance of Aurora DS for hair removal is supported by data generated in a multi-site, prospective clinical study that was carried out by a group of highly distinguished medical investigators in the US and Canada, including:

Dr. Jerome M. Garden, Northwestern University, Chicago, Illinois
Dr. Suzanne Kilmer, Sacremento, California
Dr. George Hruza, St. Louis, Missouri
Dr. Sharyn Laughlin, Laserderm, Ottawa, Ontario, Canada
Dr. Fred Weksberg, Toronto, Ontario, Canada

“The combination of both radio-frequency and optical energy in the Syneron system, known as ELOS technology, is an innovative and exciting development in the treatment of hair removal,” commented Dr. Jerome Garden. “With this approach, one may achieve hair reduction while minimizing the applied light energy and its associated undesired side effects. There is the potential to more safely treat a broader range of hair and skin colors. This technology should also have application for other skin processes that have previously benefited from laser and pulsed light systems.”

Added Domenic Serafino, President-North America of Syneron Inc.: “We are very excited to offer today’s most advanced technology for the quick, gentle, safe and effective removal of unwanted body hair. The clinical study and experience from the field proves that our unique ELOS technology is superior to any light based technology for the long-term removal of all hair and skin types, including blond, red and gray hair. Prior to ELOS technology, photon-based hair removal systems only targeted the melanin within the hair shaft in order to damage the follicle. ELOS technology targets the entire follicle as its primary target, which provides superior results.”

About Aurora DS
The Aurora DS hair removal system is designed to provide maximum safety and efficacy in removing unwanted hair from all parts of the body regardless of skin or hair type, with minimal patient discomfort Based on Syneron’s proprietary ELOS (Electro-Optical Synergy) technology, Aurora DS utilizes a unique combination of light energy, conducted RF and cooling, enabling highly selective targeting of the follicle and shaft. Effective cooling and skin impedance monitoring enables fully controllable treatment.

About Syneron
Syneron is dedicated to maximizing the synergy between electrical energy and optical energy to provide advanced solutions for a broad range of medical-aesthetic applications. The Company’s innovative patent-pending ELOS technology provides the foundation for highly efficient, safe and cost-effective systems that enable physicians and medical professionals to offer new and improved services to their patients. Founded in 2000, Syneron’s R&D headquarters, Syneron Medical Ltd., is located in Israel. Its sales, service and support subsidiary, Syneron Inc. is located in Toronto, Canada. Please visit www.syneron.com.

For more information, please contact Domenic Serafino, President-North America, at Tel. (866) 259-6661 ext. 247, email: doms@syneron.com.

Syneron Medical Ltd.Soltam Technology ParkP.O.B. 550Yokneam Illit, 20692IsraelTel: +972 4 909-7424Fax: +972 4 909-7417info@syneron-med.com Syneron Inc.100 West Beaver Creek Rd. Unit 6Richmond Hill, Ontario, CanadaL4B 1H2Tel: (1) 905-886-9235 Fax: (1) 905-886-7046 Toll Free: 1-866-259-6661
gordp@syneron-med.com

Syneron, the Syneron logo, Aurora, and the Aurora logo are trademarks of Syneron Medical Ltd. and may be registered in certain jurisdictions. ELOS (Electro-Optical Synergy) is a proprietary technology of Syneron Medical. All other names are the property of their respective owners.

</font><hr /></blockquote><font size=“2” face=“Verdana, Helvetica, sans-serif”>www.syneron.com resolves to 192.197.109.64

www.syneron-med.com resolves to 192.116.93.40

R.F.L. Technologies LTD
Michael Kreindel
Bar Rav Hai David 33
Haifa, 35592
IL
Phone: 97248339177
Fax…: 9726101189
Email: mkreindel@yahoo.com


#3

I notied they say RF, not microwave. I wonder what frequency they are using. It still could be microwave, as RF is a more general term that covers a wider range of frequencies.

RJC20001


#4

I have a message in to their President about this.

Here’s a press release with some photos:

Laser News: Aurora DS press release


#5

In response to my letter to their president, I received the following letter from Sunny Kim, Clinical Specialist at Syneron:

</font><blockquote><font size=“1” face=“Verdana, Helvetica, sans-serif”>quote:</font><hr /><font size=“2” face=“Verdana, Helvetica, sans-serif”> Hello Andrea,

Dear Ms. James,

I am the clinical specialist at Syneron, and have been asked to respond to
your inquires. The FDA issues a general clearance statement in regards to
permanent epilation, but there is no invasive probe involved with the Aurora
DS system.

>>1. Can you describe the basic mechanism(s) involved in delivering energy
into the skin?
The Aurora uses ELOS technology, Electro-Optical Synergy. A combination of
light (optical energy) and radiofrequency current (RF energy) is used to
selectively heat up the follicular structure.

>>2. Is there a needle-type probe inserted into the follicle?
There is no needle-type probe involved. The applicator tip is a chilled
surface consisting of the output window for the light and two RF electrodes.
The tip covers a surface area of 12mm x25mm.

>>3. Is there a transdermal patch or other type of conductive object which
makes contact with the skin’s surface?
There is some coupling gel applied to skin surface, and the applicator tip
is pressed directly onto the gel and skin surface.

>>4. Is there any similarity to so-called “microwave hair removal” devices,
in terms of a handpiece which directs energy into the skin.
The applicator tip is placed directly onto the skin, which allows the
chilled surface to cool the epidermis, protecting it from overheating. The
light energy is pulsed directly into the skin tissue, and the RF current is
bipolar, so it flows from one electrode to the other in a fixed geometry,
penetrating the skin tissue to about 4mm. Our treatment targets are
selectively heated up, resulting in damage to the follicle.

>>5. Do you contend that the RF energy selectively heats certain structures
in the skin, and if so, can you describe the mechanism?
RF energy heats up structures that have lower relative impedence than
surrounding structures. Impedence is inversely correlated with heat, so as
the temperature rises in a structure, RF will conduct more heat in that
area. The light energy is used to selectively raise the temperature in the
hair shaft and follicle, which targets it for further RF heating. The
impedence is monitored throughout the pulse of energy, providing on-line
tissue monitoring for increased safety and efficacy.

The use of ELOS is the the next technological breakthrough in cutaneous
esthetic procedures. I wanted to answer your inquiries in a direct manner,
but if you are interested in more literature and supporting documentation on
ELOS technology, do not hesitate to ask.

Best regards,
Sunny Kim, RN
Clinical Specialist
(866)259-6661 ext 352 office
(416)523-7856 mobile
sunnyk@syneron.com

</font><hr /></blockquote><font size=“2” face=“Verdana, Helvetica, sans-serif”>I have put in another letter regarding the specific frequency of RF energy used and have requested their medical literature. I’ll keep you posted!


#6

Thanks for the update Andrea. I find this device interesting, although I am not 100% sold on it. It will be interesting to see if they tell us the RF frequency it operates at.

The effects of RF energy on human tissue varies greatly according to frequency. 800MHz and higher is considered microwaves. Not to get too far off topic but cell phones operate in the 800-969 MHz range, so technically they are in the lower micrwave energy. Microwave ovens operate in the 1.2 GHz range.

RJC2001


#7

RJC2001, my issue with the device is their claim the the RF energy delivered from a handpiece heats targets selectively. RF energy is usually absorbed by water, so I don’t see how this claim holds up. They state that it causes additional heating in the areas targeted by the optical light, but I’d need to see some more quantified data on this before I buy it.