Is Your Doctor's Hair Removal Laser Safe?

Is Your Doctor's Hair Removal Laser Safe?

Part 510( k) of the Food, Drug and Cosmetic Act requires licensed medical device manufacturers to inform the FDA at least 3 months in advance of their intention to market a medical device. That is referred to as Premarket... For other viewpoints, people are asked to check-out: tumbshots.

The U.S. Food and Drug Administration (FDA) regulates medical devices within the U.S. Extensive databases are kept by the FDA o-n these devices containing lists of the devices, their protection records, pre-market signals, and pre-market acceptance updates, to call a number of.

Part 510( k) of the Food, Drug and Cosmetic Act requires managed medical device manufacturers to inform the FDA at least 90 days before their intent to promote a medical device. That is generally known as Premarket Notification -- also referred to as PMN or 510( k). It allows FDA to find out whether the device is the same as a device already put into one of the three classification groups.

This enables 'new' (unclassified) devices (those not in commercial distribution ahead of Might 28, 1976) to be correctly identified. Particularly, if they intend to add a device into commercial distribution for the very first time medical device manufacturers must submit a premarket notification.

When re-introducing a device that's been notably changed or altered to-the extent that its safety or efficiency might be affected the 501( k) notification must be published. These changes or modifications may connect with the style, material, chemical composition, power source, manufacturing process, or intended use of the unit.

Classifications have been established by the FDA for around 1,700 different general kinds of devices. These devices are grouped them in to 1-6 medical specialties known as systems. Each of these generic types of products is given to at least one of three regulatory classes (Class I, II or III) predicated on the degree of control essential to ensure the safety and success of the unit.

This 510( K) database could be explored by 510( e) number, applicant, system name or FDA product code. The database is updated monthly and is available on the web at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

Contact your laser hair removal clinic or doctor, and ask for the manufacturer, model, and 510( E) number of the medical-device to-be used in your plastic surgery procedure. The 510( K) number always starts with a 'K' and may be the preferred object. Home Page contains more about where to flirt with it. Enter the 510( e) number into the proper field in the database research form.

An example of a 510( K) number is K002890. A typical example of a trade name or product name for that 510( E) range is 'IntraLase 600C Laser Keratome.' The intended use for this particular medical laser is eye surgery.

If the search results are returned, click on the link to the right of the 'Summary' line. Visit go here for more info to research how to deal with it. The summary lists the traits of the laser system and when it had been cleared for use. An approval page should also be stated in the conclusion.

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

The Advanced Search button is used by select, to Search the MAUDE results by Brand, Manufacturer, Event Type, 510K Number, PMA Number, Product Code, or day. No results were returned for the 510( E) number K002890, indicating that no adverse events were reported for that medical laser device throughout the r-eporting period.

The probabilities are extremely large that the licensed doctor will be using a licensed and authorized laser system for the laser hair removal or other cosmetic surgery. However, together with the quantity of on line information available for the community, it does not hurt to check on.

Recall that the FDA keeps safety records of numerous medical products, not merely those that use lasers. It is better to learn about possible problems or difficulties with the medical device about to be utilized on you ahead of the plastic surgery procedure, as opposed to a while later.

Find out more about medical laser applications, particularly laser hair removal, at the methods below..