Is Your Doctors Hair Removal Laser Safe

Is Your Doctors Hair Removal Laser Safe?
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,​ premarket notifications,​ and ​ premarket approval notices,​ to​ name a​ few.
Section 510k 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​ 510k. ​
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 501k 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 510K database can be searched by 510k number,​ applicant,​ device name or​ FDA product code. ​
The database is​ updated monthly and ​ is​ found online at ​ http//
Call your laser hair removal clinic or​ doctor,​ and ​ ask for​ the​ manufacturer,​ model,​ and ​ 510K number of​ the​ medical device to​ be used in​ your cosmetic surgery procedure. ​
The 510K number always starts with a​ K and ​ is​ the​ preferred item. ​
Enter the​ 510k number into the​ appropriate field in​ the​ database search form.
An example of​ a​ 510K number is​ K002890. ​
An example of​ a​ trade name or​ device name for​ that 510K 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//
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​ 510K 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​ doesnt 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.

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