how safe is your doctor's hair removal laser?

The U.S. Food and Drug Administration (FDA) regulates medical devices in the U.S. The FDA keeps extensive databases on these devices containing lists of the devices, their safety records, pre-market notifications, and pre-market approval notices, to name a few.

Section 510(k) of the Food, Drug and Cosmetic Act requires regulated medical device manufacturers to notify the FDA at least 90 days in advance of their intent to market a medical device. This is known as Premarket Notification -- also called PMN or 510(k). It allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.

This allows "new" (unclassified) devices (those not in commercial distribution prior to May 28, 1976) to be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time.

The 501(k) notification must also be submitted when reintroducing a device that has been significantly changed or modified to the extent that its safety or effectiveness could be affected. These changes or modifications might relate to the design, material, chemical composition, energy source, manufacturing process, or intended use of the device.

The FDA has established classifications for approximately 1,700 different generic types of devices. These devices are grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes (Class I, II or III) based on the level of control necessary to assure the safety and effectiveness of the device.

This 510(K) database can be searched by 510(k) number, applicant, device name or FDA product code. The database is updated monthly and is found online at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

Call your laser hair removal clinic or doctor, and ask for the manufacturer, model, and 510(K) number of the medical device to be used in your cosmetic surgery procedure. The 510(K) number always starts with a "K" and is the preferred item. Enter the 510(k) number into the appropriate field in the database search form.

An example of a 510(K) number is K002890. An example of a trade name or device name for that 510(K) number is "IntraLase 600C Laser Keratome." The intended use for this particular medical laser is eye surgery.

When the search results are returned, click on the link to the right of the "Summary" line. The summary lists the characteristics of the laser device and when it was cleared for use. An approval letter should also be listed in the summary.

You may also wish to examine the FDA MAUDE (Manufacturer and User Facility Device Experience) database. This database contains reports of adverse events involving medical devices. The link to this database is http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm

To Search the MAUDE listings by Brand Name, Manufacturer, Event Type, 510K Number, PMA Number, Product Code, or date, select use the Advanced Search button. No results were returned for the 510(K) number K002890, indicating that no adverse events were reported for that medical laser device during the reporting period.

The chances are very high that a licensed doctor will be using a licensed and approved laser device for your laser hair removal or other cosmetic surgery. However, with the quantity of online data available to the public, it doesn't hurt to check.

Remember that the FDA keeps safety records of many medical devices, not just those that use lasers. It is better to learn about possible complaints or problems with the medical device about to be used on you before the cosmetic surgery procedure, rather than afterwards.

meditation and stress

Do you remember seeing comedy shows or skits when you were young where someone is practicing meditation. There was usually one person closing their eyes and "ohm"ing while the other person tried to imitate them or simply made snide remarks. While we used to look upon meditation as being funny, ridiculous, or just plain odd; we now know about all the benefits it has to offer. Originally, meditation was used to focus and gain religious knowledge. Now, it is commonly used to reduce stress and live longer, happier, healthier lives.

So why is mediation so helpful for relieving stress? First of all, it helps focus the mind on something that is deeply and spiritually rooted. By focusing on one thing, you're forced to forget the world around you and all the stressors that come with it. By closing your eyes and sitting in a quiet room, you also filter out the sights and sounds that may stress you. Meditation also helps repair the physical and mental damage caused by stress. The chemicals present in your body actually change during meditation making you more relaxed and peaceful.

The relaxing benefits from above are only the short term benefits Those factors are only successful in filtering out stress that you've already experienced and making you relaxed during and after your meditating. The real benefit of meditation is its longer term effects.

If practiced on a daily basis, meditation can actually balance the levels of hormones and other stress related chemicals on a day-to-day basis; even when you're not meditating. This means that meditation will not only help you unwind at the end of a stressful day, it can also leave you more peaceful and less stressed during your long day at work.

The best part about meditation is, unlike yoga, it requires no special physical skills. While good meditation requires mental skills, you can start small and build your way up as you get more practice. Here's how to get started.

* Find a quiet room and sit in a comfortable position. There is no specific "better" position, just one where you feel comfortable and can relax.

* Close your eyes and relax your muscles. Do this by focusing on each individual muscle, starting at the feet and working your way up. Focus on the stress leaving each muscle as it relaxes.

* Begin to breathe slowly while you repeat your mantra. This can be anything from the traditional "ohm" to something you find personally important. If you are religious or spiritual, you can chant something related to your beliefs.

* If you find your mind wandering, don't beat yourself up about it; simply remain calm and return to your focus word.

* After 15 to 20 minutes, you can stop meditating and sit quietly for a few minutes before you return to your regular life.

By doing this regularly, you will train your mind and body to be more relaxed, peaceful and focused. You will find this not only affects your stress levels, but also your physical and mental functioning.