FDA has NO Mandatory performance standards for IPL devices+

FDA Adverse Event Information, Medical Device Approval Process, and FDA Corruption

FDA has NO Mandatory performance standards for IPL devices+

PostPosted by redbysciton » Wed Mar 18, 2015 11:42 am

Here's the excerpt from the FDA page at http://www.fda.gov/radiation-emittingpr ... efault.htm :

"Product Specific Questions

Q35) Are Light Emitting Diodes (LEDs) or Intense Pulsed Lights (IPLs) subject to the laser regulations and reporting?
LEDs and IPLs do not meet the definition of a laser, namely:
21 CFR 1040.10(b)(19) Laser means any device that can be made to produce or amplify electromagnetic radiation at wavelengths greater than 250 nm but less than or equal to 13,000 nm or, after August 20, 1986, at wavelengths equal to or greater than 180 nm but less than or equal to 1.0*106nm primarily by the process of controlled stimulated emission.

There is no existing FDA performance standard for LED or IPL products. They are not subject to Product or Annual reports under 21 CFR 1002. However, as they are radiation-emitting products, the manufacturers of these products would still be subject to the general requirements in Title 21 CFR 1000 through 1005, specifically, accidental radiation occurrence notifications and notifications of defect, 21 CFR 1003 & 1004."

Apparently the FDA thinks IPL is about as harmless as an LED lightbulb. Ha!
redbysciton
 
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