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.
Learn more about medical laser applications, especially laser hair removal, at the resources below.
Hair Removal Laser Equipment
There are so many ways in which men and women have approached hair removal, such as shaving, cream hair removal, and waxing. All of these practices are in fact very popular and widely used around the world. But, the hair will grow back and you will once again have to watch what you wear until you go over the hair removal procedure.
Laser hair removal is one of a revolutionary way to approach the elimination of the hair on the entire body as it will be removed forever. Laser hair removal can be applied safely on the whole body, face and the bikini area without even to worry about the side effects, rashes or the hair ever growing back. For successful laser hair removal you may be necessary to attend a few sessions, which are not cheap but certainly worth the effort and money.
To facilitate laser hair removal essential laser hair removal equipment is necessary, and that is the none other than the laser machine. There are various types of laser hair removal equipment available and depending on the budget, amount of clientele you anticipate and facilities you have need of from it you can choose the best one that fits your needs.
Most laser hair removal equipment will also be competent to perform dermatology applications, aesthetics, leg veins corrections, haemangiomas, vascular treatment and of course hair removal. Although most laser hair removal equipment is expensive. Nevertheless, financing can be made available through your bank or other financing agents, which sometimes are directly connected with the companies that manufacture and distribute the hair laser removal equipment.
If you are on the lookout for some bargains on laser hair removal equipment, you may find them in salon that are closing or moving and want to get rid of their existing equipment. To find these bargains will have need of following local newspapers, or even placing an advertisement in the newspapers that you are looking for second hand laser hair removal equipment.
Occasionally the manufacturers of the laser equipment may be able to help and direct you to those who wish to sell their existing machines as at times people will contact the manufacturers first to enquire if they would like to purchase their product back at a discounted price.
Finding laser hair removal equipment that is in good condition should, nevertheless, be your primary priority because you will be dealing with very delicate parts of the human body and any malfunction can be devastating. If achievable, try and ensure you have some type of guarantee from whom you purchase second hand equipment and also try it out prior to you close the deal. New equipment will normally come with guarantee and free service and that is one of the reasons why you should try and always purchase new products if possible.
More About Laser Hair Removal Before and After
If you learn that you are in fact an ideal candidate and thus want to learn more about laser hair removal before and after, subsequently one of the first things that you are going to want to learn about is the fact of how laser hair removal before and after is a very serious topic, as you are going to want to be familiar with about everything that is included here and about whether or not there are any risks or complications that are implicated here.
There are fundamentally risks whenever you get any sort of operation or procedure done, and this is not any different here. For example, you may find that your skin is incredibly red for a while after, or irritated and uncomfortable, and this will in general depend on the doctor that you go to as well as how long the actual process ends up taking.
In addition you can ask your doctor about available creams and lotions that you can get to help with this, while nothing is going to take it away completely. Still, there are also certain precautions that you can take in order to make yourself as ready and hopefully as protected against any risks and complications as you can be.
You are going to want to talk to your doctor about this, in order that you can get the best idea overall and be as informed as possible, because your doctor is the professional here and they will be able to consequently let you know the most important facts that you are going to need to know, and therefore you are definitely going to want to make an appointment or two before the actual first procedure so that you can talk with them and get all of your questions answered.
Both Doug Smith & Cindy Heller are contributors for EditorialToday. The above articles have been edited for relevancy and timeliness. All write-ups, reviews, tips and guides published by EditorialToday.com and its partners or affiliates are for informational purposes only. They should not be used for any legal or any other type of advice. We do not endorse any author, contributor, writer or article posted by our team.
Doug Smith has sinced written about articles on various topics from Personal Desktop, Site Promotion and Home Management. Visit and for Free Laser Hair. Doug Smith's top article generates over 18100 views. to your Favourites.
Call Center Software Voip Much of the bandwidth requirements for your services can easily be assessed and discussed over email or phone with a VoIP provider or reseller