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Recertification
Interlectric Corporation is registered with the FDA to perform recertification of your tanning units.
What is recertification?
Recertification is an exciting new method to make your tanning unit competitive with new units, including those using high UVB lamps, and yet still be compliant with Federal regulations. If the bulbs in your unit are not specified on the label or you wish to use a tube other than that specified, you can still use those bulbs if you recertify the unit according to regulations, which will automatically include new labeling.
Why recertify?Where regulation is a concern, recertification will bring units into compliance.
If you do not currently qualify for insurance, recertification will bring units into compliance, and thus make your operation insurable.
Through recertification, a salon owner will have the correct exposure schedule determined for their unit.
As the market changes, the salon will have the opportunity to upgrade their unit to the most recent bulbs through recertification.
With which type of tube may I recertify my unit?You may recertify your unit with any tube that has been registered with the FDA by the manufacturer.
How do I determine which tube to recertify with?The individual market conditions in your area will ultimately determine which type of tube or tubes you use. However, the major factors affecting your decision are as follows:
Exposure Time: The salon owner should decide whether their customers are interested in the fastest tanning session possible or whether the relaxation component of a longer session is desired. The higher the output of the tube you use, the shorter the tanning session. Due to different phosphor designs, the higher UVB% is not always indicative of higher output. A knowledgeable supplier should be able to compare the output of your present tube with any tube you might be interested in.
Color Quality: Higher UVB% tubes create a better distribution of melanin, as well as hyperplasia, or thickening of the skin. Through repeated tanning sessions, the higher UVB% tubes have the advantage of increasing the tanning plateau, giving a darker tan. In addition, the thickening of the skin reduces the risk of sunburn, especially important for tanners preparing for outdoor vacations.
Color Quality: While understanding that skin type will also affect the color of tan, generally, lower UVB% tubes will tend to create a golden-brown tan, while higher UVB% tubes will tend to create a deeper tan. Tubes with UVA towards the longer wavelength end of the UVA spectrum also tend to create a golden-brown tan.
Erythema: The amount of red showing after a tanning session will depend on UVB weighted output. The higher the weighted output in the UVB range, the greater the potential for some show of red after exposure. For customers who relate tanning to a show of red, the higher weighted output UVB tubes will probably be desirable. For those who do not want to see any red, stay away from the higher weighted output UVB. Again, weighted UVB output is not the same as UVB%. A knowledgeable supplier should be able to indicate the relative weighted UVB output of different tubes.
How do you recertify an indoor tanning unit?With the aid of any qualified recertification specialist, you may recertify your unit for the tube of your choice. The recertification specialist needs to measure the spectral output of your full unit with your new, unused tubes as specified in the Federal regulations. From this information, the specialist calculates the Te and Tm of your system to provide you with your new exposure schedule. The recertifier must have equipment of sufficient accuracy to make the above measurements.
What are Te and Tm?
Te and Tm, whichever is less, measures the maximum exposure time and exposure schedule for any tanning unit. Te and Tm are calculated by multiplying the spectral output (irradiance measured by the recertifying specialist at one nanometer increments between 200 and 400 nanometers) by a weighting factor specified by the FDA in section 21 CFR 1040.20.
What is 21 CFR 1040.20?
21 CFR 1040.20 is that section of the FDA regulations which specifies the performance standards for sunlamp products. It became effective May 7, 1980 and was amended September 8, 1986. Recertification must comply with the standards noted in this section.
How do we know the recertification is accurate?
Each recertifier must design and utilize a quality assurance program filed with the FDA that insures that the unit is in compliance with Federal regulations.
What if my timer has an interval greater than the maximum exposure on my new schedule?
Your maximum timer interval cannot exceed the maximum recommended exposure time. If in the course of recertification it is found that your timer exceeds allowable limits, you will need to equip your unit with a new timer.
What happens after we have a new exposure schedule?
After your new exposure schedule has been calculated and your new timer is in compliance, the recertifier will send you new labeling and a recertification manual. At that point in time, your unit is in compliance with FDA regulations.
Can I use another tube after recertification?
Only the tube noted on your labeling, or a compatible tube that is equivalent according to 21 CFR 1040.20 may be used on any tanning unit.
Who is qualified to do a recertification?To be recognized as a valid recertifier, in compliance with Federal regulations, the recertifier must file an initial report with the FDA. Each recertifier must receive an acknowledgement from the FDA noting receipt of their initial report and the assignment of an accession number.
Is insurance available after recertification?Yes. Currently, your salon may be insured provided your salon is in compliance. Since recertification puts your tanning units in compliance, your salon would qualify for coverage.