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Ontharing
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Wetenschappelijk
onderzoek
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a.
de ELOS
b. de Lightsheer Diodelaser
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de ELOS
De internationaal in hoog aanzien staande
specialisten en wetenschappers die het effect van de ELOS hebben
onderzocht, en enthousiaste gebruikers zijn geworden:
-
Antonio Del Giglio M.D.
- James Shaoul M.D
- Dr. Sharyn A. Laughlin M.D, FRCP(C), Assistant Professor, Department
of Medicine, Division of Dermatology, University of Ottawa, Director
Photobiology Unit, Ottawa Civic Hospital
- Dr. Jerome M. Garden, Associate Clinical Professor of Dermatology,
Northwestern University, Chicago, Illinois
- Dr. Suzanne Kilmer, dermatoloog, Sacramento, Californie
- Dr. George Hruza, St. Louis, Missouri
- Dr. Fred Weksberg, Toronto, Ontario, Canada
- Michael Kreindel, Ph.D
- Amir Waldman, Ph.D
- dr. Stephen Mulholland, plastisch chirurg, Toronto, Canada
- dr. Patrick Bitter, dermatoloog, Californie
- dr. Gary Lask, plastisch chirurg, Californie
- dr. Raulin, dermatoloog, Duitsland
- dr. Potvin, dermatoloog, Belgie
- dr. Schroeder, dermatoloog, Maastricht, Nederland
Twee
artikelen uit maart 2003 hebben we overgetypt, met daarboven een
korte Nederlandse samenvatting:
over het
effect op grijze en witte haren
en over de
veiligheid en effectiviteit bij de getinte huid (hier zijn wij
het niet mee eens vanuit onze ervaringen!- redactie)
Hieronder ook
de conclusie van de Amerikaanse `Keuringsdienst van waren', de Food
and Drug Administration (met foto's);
en daaronder de toestemming van de EC (voor Nederland: passend in
het Besluit Medische Hulpmiddelen); U kunt zelf ook bij de FDA de
originele brieven
van aanvraag en toestemming inzien.
`FDA-clearance'
betekent dat het controle-orgaan van de overheid voor nieuwe medische
methoden en voedingsmiddelen een grondige studie heeft verricht. Deze
studie wordt gedaan aan de hand van verslagen van medici over hun
bevindingen in de praktijk en aan de hand van rapporten van wetenschappelijk
onderzoek, dierproefvrij.* Op grond van deze documenten wordt een
conclusie getrokken over al dan niet toestaan van een nieuwe techniek.
Het is een veiligheids- en effectiviteitsbeoordeling. Hieronder het
persbericht over de toelating van het systeem ELOS - ELectrical-Optical
Synergy, oftewel het ontharen met het apparaat Aurora. |
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16
juli 2002 - Yokneam, Israel, and Toronto, Canada
Aurora DS ELOS technology receives FDA clearance for hair
removal |
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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(TM)
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(TM) (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 e n able 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 U.S. and Canada, including:
Dr.
Jerome M. Garden, Northwestern University, Chicago, Illinois
Dr. Suzanne Kilmer, Sacramento, 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 ha ir rem oval,"
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 gr ay hai r . 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.
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About
Syneron
Syneron is dedicated to maximizing the synergy between electrical
energy and optical energy to provide advanced solut io ns
fo r 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
http://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.
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
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Een grote ontharingsketen
in Amerika ''American Laser Centers'' met 31 vestigingen werkt sindsdien
alleen nog maar met de ELOS. Zie
English
* de conclusie
bij de FDA wordt getrokken door het bestuderen van bevindingen van
artsen uit de praktijk met menselijke vrijwilligers. Er zijn geen
proefdieren voor gebruikt. We mogen stellen dat de Aurora zelf dierproefvrij
is.
Maar hij combineert twee oude technieken die ooit wel zijn uitgetest
op dieren. Voor de fysiotherapeutische hoogfrequente stroom zijn
begin vorige eeuw proeven gedaan, en de flitslamp is circa tien
jaar geleden op de stugge haren van een varken uitgeprobeerd (wel
onder verdoving gelukkig). Wij vinden dit eigenlijk ethisch niet
verantwoord.
De Israelische fabrikant van de Aurora heeft gelukkig zelf geen
testen op dieren gedaan. Zij zijn ''kosjer'' net zoals veel dierproefvrije
cosmetica: veel nieuwe cosmetica (deodorants, waspoeders, tandpasta,
zonnebrandlotions, etc.) wordt nog steeds op dieren uitgetest, maar
bijvoorbeeld het Kruidvat Huismerk is dierproefvrij. Dit betekent
niet dat er nooit in het verleden voor een ingredient proeven zijn
gedaan, maar dat wordt dan niet door het Kruidvat gedaan voor de
ontwikkeling van het produkt.
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de
toestemming van de EC. Voor Nederland: passend in het Besluit
Medische Hulpmiddelen
DECLARATION
OF CONFORMITY MEDICAL DEVICES
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We hereby
declare that the distributed CE marked products, specified
in the annexed product list, are covered by the "CE Marking
of Conformity Certificate", reference number: 2013886CE01,
issued on 2001 and delivered by N.V.-KEMA, Arnhem, The Netherlands,
Notified Body Identification Number 0344, and conform to the
required technical documentation, in accordance with Annex
VII of the law `Besluit Medische Hulpmiddelen' of The Netherlands
transposing the "EC-Directive", the Council Directive
93/42/EEC of 14 June 1993, concerning medical devices.
In addition,
we ensure and declare that the distributed CE marked products,
as mentioned and falling within Class IIA, meet the provisions
of the ED-Directive which apply to them.
This
declaration is based on the application of the Quality System
approved for the manufacture and final inspection of the products
concerned, in accordance with Annex V of the EC-Directive.
The conformity of the production quality assurance set out
in Annex V, is described in the said CE Marking of Conformity
Certificate, issued and delivered by N.V. Kema.
This
declaration is supported by the Quality System certification
based on the harmonized standards ISO 9001/ EN 46001, Quality
System Certificate with reference number: 23420, issued on
21.08.2001 and delivered by the "Standards Institution
of Israel".
This
Declaration of Conformity covers Aurora as specified in the
productlist belonging to this declaration, and is valid for
all products concerned bearing the CE marking and manufactured
at the following site(s):
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A to Z
Electronics Ltd.
5 Hataasiya Street
Migdal Haemek 10550, Israel |
Syneron
Medical Ltd.
Industrial Zone, P.O.B 550
Yokneam Illit. 20692, Israel |
| Yokneam
Illit, Israel, July 16, 2002 General Manager, Dr. Michael Kreindel |
| Representative: |
Syneron
GmbH
Ludwig-Ganghofer-Strasse 7
D-82031 Gruenwald, Germany |
| Gruenwald,
Germany, July 16, 2002 General Manager, Susann Edel |
| Annex:
Product list - DC06183 |
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b. de Lightsheer
Diodelaser
volgt
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Deze
site heet ook:
nooit meer scheren . nl |
©
KORPOS, Donna en Michelangelo, februari 2003. laatst gewijzigd op 30 juli
2009. .
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