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ITA Today Promoting Responsible Sun Care and Sun Burn Prevention. Founded in 1999, the Indoor Tanning Association today represents thousands of indoor tanning manufacturers, distributors, facility owners and members from other support industries. |
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07-16-2014, 07:30 AM | #31 (permalink) | |
Team TanTalk Join Date: Aug 27 2002 Location: East Coast Age: 56
Posts: 2,888
Rep Power: 22 | Re: FDA Reclassification Summary Quote:
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07-31-2014, 11:00 AM | #32 (permalink) |
Join Date: Oct 22 2013 Location: LAS VEGAS, NV
Posts: 10
Rep Power: 0 | Re: FDA Reclassification Summary Just some food for thought. We all post lists of medications for our clients. On that list are several types of "steroids." This list is a guideline to help our clients tan responsibly. There are hundreds if not thousands of different types of steroids that are placed in the foods we eat. All regulated by the FDA. These steroids are then in our bodies as we march out into the daily sunshine. THESE are the main causes of melanoma ... and are the reason so many people contract melanoma on a yearly basis. If the FDA allows these steroids to be placed in foods ... it is contradictory for them to label our industry as the main cause of melanoma. Just sayin' |
07-31-2014, 12:25 PM | #33 (permalink) | |
Join Date: Mar 18 2005 Location: GA
Posts: 1,153
Rep Power: 20 | Re: FDA Reclassification Summary Quote:
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10-21-2014, 04:39 PM | #36 (permalink) |
Join Date: Oct 13 2006
Posts: 4
Rep Power: 0 | Re: FDA Reclassification Summary First, it's going to be tough to find new equipment after the deadline (sorry... should of read August 26, 2015. As of yet I don't know of any tanning bed manufacturer that has a 510k for any of their models. Most companies won't even bother to apply. Those that do, if any, with limit their available models. Secondly, lots more testing/certification/requirements are required for 510K & class ll medical devices. In order to pass electrical testing most units will require that their intensity be dramatically reduces which will probably be the end of High Pressure or High intensity units. Third, higher costs/less competition will probably mean a higher price tag. Less selection, lower output, longer session times, higher costs = doesn't sound appealing to a new salon owner. |
10-21-2014, 05:13 PM | #37 (permalink) |
Team TanTalk Join Date: Aug 27 2002 Location: East Coast Age: 56
Posts: 2,888
Rep Power: 22 | Re: FDA Reclassification Summary WRONG on everything. All the companies that I know of are well on their way. Ergoline UWE KBL Heartland Suncapsule and more These alone count for probably 90% of the units sold in the commercial arena. The 510K process in pretty painless. No company will have to reduce their units output at all. Please stop posting completely false and misleading information. |
10-22-2014, 09:57 AM | #38 (permalink) |
Join Date: Oct 13 2006
Posts: 4
Rep Power: 0 | Re: FDA Reclassification Summary 510K is anything but painless. It's complicated, time consuming and expensive. I'm not sure to whom you're talking to that's painting such a rosy picture, but ask them next time whatever happened to their Red Light units. All that was needed was an easy breezy 510k. Besides the 510K, there's also class II requirements. Most tanning units/models available on the market today would fail on EMF testing alone. But, then again what do I know. We'll see in a years time. |
10-22-2014, 10:58 AM | #39 (permalink) |
Join Date: Feb 10 2005
Posts: 8,304
Rep Power: 35 | Re: FDA Reclassification Summary I've always heard what Eddyo is saying. Robert is the talk of a backlog for 510K's in the news not true?
__________________ "under exposure to UV rays is as dangerous as overexposure....this is D life" eileen |
10-22-2014, 11:19 AM | #40 (permalink) |
Team TanTalk Join Date: Aug 27 2002 Location: East Coast Age: 56
Posts: 2,888
Rep Power: 22 | Re: FDA Reclassification Summary No none of it is true. NONE. We (ITA) have met with the FDA and communicated with them on multiple occasions and expect the 510K process to be fairly painless. Each current manufacturer is expected to file one (1) 510K for all their currently marketed products only. Besides for some labeling changes and such the units do not need to be changed in anyway. It is expected to cost somewhere between 5-10K per 510K filed. They do not expect any delays with reviewing the 20 or so 510K's they will be receiving in the next year from the tanning industry. Your analogy to the red light beds is also wrong. There are no predicate devices for the red light units. In the case of tanning beds there are. BIG difference. Why not inform yourself before posting misleading information? Last edited by Robert K; 10-22-2014 at 11:29 AM. |
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