Kevin Apgar, President of Cosmedico helps host, with six other business professionals, at the upcoming Grimm for Congress/US Congressman Michael Grimm invited gathering fundraiser on January 20, 2012 from 7-8:30pm at the Teaneck Marriott at Glenpointe, Teaneck NJ.
* For the 8th Consecutive Year, Cosmedico Receives Winner of the Industry Choice Award, 2011 from Island Sun Times for the CosmoLux® VHR 9k90®!
The ‘best of the best’ salon owners and the many loyal readers of Island Sun Times voted as their favorite the Cosmedico Light, Inc Low-Pressure Tanning Lamp ,> the Cosmolux® VHR 9K90® 160W! Cosmedico´s innovative introduction of the 9K90® series of tanning lamps in 2003 was a direct result of listening to the salon owners and set a new tanning lamp standard for the 21st century!
The 9k90® family of lamps was created with the objective of producing never-before-attained UVA and with UV maintenance of +90% at 100 hours. The revolutionary 9k90® technology is produced using a precise blend of four phosphors - a blend never before used in lamp product and fully supported by a Cosmedico US Patent. It produces a spectrum unlike that of any other low pressure sunlamp. Peak power has been ‘shifted to the right’ and are found at +/- 365 nm-a spectral power distribution that mirrors filtered high pressure lamps. CosmoLux®9k90 lamps provide all the benefits of high pressure tanning in a low pressure format.
"The 9K90® is a superb product that was developed as a result of requests from salon owners that Cosmedico offer a lamp with more UVA and longer usable life to give the salon owner a better value - more bang for the buck! This is truly an honor for all of us at Cosmedico Light and we thank all our customers . . . for helping the 9k90 remain at the top" Kevin Apgar, President noted after hearing the news this week of winning the Industry Choice Award from Island Sun Times.
* Letter from the FDA regarding the use of Red Light Therapy...
The Food and Drug Administration (FDA) is aware that some tanning salon owners are removing the original ultraviolet (UV)-emitting tanning lamps from their tanning beds/booths and replacing them with lamps that emit red light. These salon owners are then selling sessions in the red-light units with a range of indications and promotional claims, including ones pertaining to:
- reversal of sun or UV damage to skin
- wound healing
- increased blood flow/circulation
- reduced pain and/or inflammation
- treatment of acne
- reduction of appearance of wrinkles, pigmentation spots, stretch marks, and /or scarring
- skin rejuenation, restoration, oxygenation, and/or hydration
- collagen/elastin production/reorganization
- skin structure, elasticity, and /or metabolism
Ultraviolet tanning beds/booths/lamps meet FDA´s definition of "device" and "electronic product" at sections 201(h) and 531 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Tanning lamps are subject to an electronic product performance standard, and are generally 510(k)-exempt. See 21 CFR 878.4635, part 1010 and 1040.20.
Replacing the orginal ultraviolet lamps with lamps that emit red light and are intended for uses such as those listed above creates a new type of product that is also a "device" and an "electronic product" under the FD&C Act. Exposure to red light has been scientifically shown and is understood by consumers to affect skin structre, for example by reducing wrnkles for months after treatment, which may be the result of new collagen formation or reorganization, or repair of elastin damage. Claims such as those listed above would cause the product to meet one or both of the "device" definitions at sections 201 (h)(2) and (3) of the FD&C Act.
Red lights intended for uses such as those listed above would not fall under 21 CFR 878.4635, and would not be 510(k)-exempt (they also would not fall under 21 CFR 1040.20, but would be subject to the regulations generally applicable to electronic products at parts 1000 - 1005). Unless and until such device receives 510(k) clearance or premarket approval from FDA, it would be an adulterated and misbranded device that may not be marketed for sale. Red light therapy systems intended for uses such as those described above may fall under 21 CFR 878.4810, 878.5400, or 890.5500, depending on the technology and the claims made. For devices that fall within one of these classification regulations, the proper application to file is the 510(k) or "Premarket Notification."
FDA requests the Indoor Tanning Association´s assistance in getting this message out to its members. FDA is also communicating this message to state radiation control programs. Some states have expressed concern about this practice to FDA and have already taken action on their own.
Some useful links to the FDA website relevant to this issue are shown below:
The instructions on how to submit a Premarket Notification application can be found at this link. The sunlamp regulations and other resources can be found at this link.
Contacting FDA
Questions about the requirements for clearance of red light devices may be directed to Richard Felten in the Office of Device Evaluation, CDRH, 10903 New Hampshire Avenue, WO-66, Silver Spring, Maryland 20993 or by email at Richard.Felten@fda.hhs.gov
Questions about FDA radiation control requirements for electronic products may be directed to Sharon Miller in the Electronic Products Branch, Office of Communication, Education, and Radiation Programs, CDRH, 10903 New Hampshire Avenue, WO-66, Silver Spring, Maryland 20993 or by email at Sharon.Miller@fda.hhs.gov
* Want to read the weekly news from the Joint Canadian Tanning Association (JCTA)?
- Tanning bed use declines with more sunless tanning products
- Sunless Users Still Seek Sun: Study
- Call for vitamin D supplements to tackle Scots MS rates
- Avoiding the Sun to Avoid Skin Cancer? Recent Studies Challenge That Advice.
- Want to live a few more years? Take vitamin D supplements!
- Quote of the Weak:Derm Leader Wrong On D Math
- Ban tanning bed use by minors, MP urges
- A Surprising New Skin Cancer Risk
- NAD recommends Merck to drop sunscreen advertising claims
Click Here to log in to read these articles.
* Check out the article on WebMD in how Vitamin D can help protect against Diabetes high risk people...
http://diabetes.webmd.com/news/20110628/study-vitamin-d-may-cut-risk-of-diabetes?src=RSS_PUBLIC
* Check out the January 2012 Tan Expo/New York Conference Photos!
http://www.pctan.com/promos.php
* JK North America Visit with Cosmedico Light
Cosmedico was happy to host Jens-Uwe Reimers, Chief Sales Officer, JK Worldwide and Bobby Wagner, Sales Manager JK Light at their Weymouth, MA office in January 2012. During the visit Bobby Wagner got to see his first hockey team as the Boston Bruins beat the Winnipeg Jets. The trip was more than just fun as some visits to local salons were made as well.
* Legislative Alert -- 10% Federal Tax Proposed on Tanning Services
Help us tell Congress to take the Tan Tax out of the Healthcare Reform Bill!
http://www.repealtantax.com/
Our team on Capitol Hill has learned that the proposed tan tax was added at the very last minute to the Senate Leadership’s Healthcare Package at the behest of Senate Majority Leader Harry Reid, (D-NV). The tax is part of a deal to secure the support for the legislation from the American Medical Association, the American Academy of Dermatology and replaced the “Botax”, a tax on elective cosmetic medical procedures.
The Senate is on track to complete consideration of this proposal on Christmas Eve and the Congressional leadership has indicated its desire to negotiate and pass the final conference report through both the House and Senate before the President’s State of the Union address in late January.
Time is of the essence.
Our lobbyists have begun their direct outreach to key members of the House and Senate. We have also been working to focus media attention on this unprecedented and unfair tax and are working with our PR team to bolster our PR and media efforts.
* We are now calling on you to engage your employees, families and customers to speak out against the tan tax.
Go to the ITA website www.theita.com or Click on this link: TELL CONGRESS TO TAKE THE TAN TAX OUT OF HEALTHCARE REFORM to register your opposition with your Senators and Member of Congress.
On the website, you will see two links, one for owners, employees and their families, one for customers. Enter your zip code and address to find your representative and senators. You can either personalize the letter already present in the message field or send it as it is. The link will also give you phone numbers for each office. In addition to your email, call and tell Congress how you feel about this tax!
Finally if you have facilities or businesses in the following states, please e-mail the ITA as we want to have special lobby efforts directed to key Members of Congress from:
- Nevada
- Montana
- Arkansas
- Nebraska
- Maine
- Maryland
- Flordia
- Indiana
- Tennessee
Please send this to your friends, family and customers and let us know if you have any questions.
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Compatibility Chart? Download it here. 
2008 Product Catalog. Download it here. |
