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Sunday, February 27, 2011 4:16:16 PM

Re: Kingfisher7234 post# 38277 Post # of 38286

That's a standard tagline

exact same final 2 paragraphs in TWO separate communications to another company. In business communications, the stuff that comes AFTER the signature isn't original thought from the writer, but simply standard verbiage appended to ALL letters


On Jun 21, 2010, at 10:34 AM, Velez Cabassa, Aileen wrote:

Dear Mr. XXXX:
This is in response to your email below to the Food and Drug Administration (FDA). See below for the answer concerning the sale of IR lasers.


1.) Can an individual/consumer be prosecuted for buying an infrared laser?

FDA may, through the U.S. Department of Justice (DOJ) file a civil complaint in U.S. District Court to restrain violations of the prohibited acts. In addition, FDA may seek to enjoin dealers and distributors of electronic products from disposing of or further distributing any products that fail to comply with performance standards. FDA is also granted authority to seek civil monetary penalties for certain violations. Civil monetary penalties can be as high as $300,000 for a related series of violations.


2.) Is it illegal for an individual/consumer possess an IR laser?

It depends on the type of product. If the laser is a medical device it will need to meet its regulatory requirements. For example, if its a device that requires a prescription you will need to have one prior to purchasing. And if the IR is classified as a class IIIb or class IV light show device you will need to have a current approved variance by the FDA.

3.) Is it illegal for an individual/consumer use/operate an IR laser? (Assume they are doing so only in a safe and responsible manner.)

The FDA regulates the manufacturing of the device and in some cases its use. The purpose of FDA's regulation of radiation emitting products is to prevent unnecessary radiation exposure when using and operating such products. The distribution and use of the IR laser is regulated at the State level. You will need to contact your local State radiation-control Agency for the specific requirements.
An example of when the FDA would regulate the use of IR is when for Class IIIb and class IV laser light show projectors, identified as such on the label . These may only be sold by or to individuals or firms with current, approved laser light show variances from FDA. Another example is a laser product that is advertised as uncertified component . These may only be sold to other manufacturers and may not be sold to the public for general use.

Please feel free to contact me if you need any further assistance.


Aileen I. Velez Cabassa, M.S.
Consumer Safety Officer
Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration (FDA)
Telephone: [phone]
Fax [phone]
[e-mail]


This response represents to the best of my judgment how the device should be regulated, solely based upon a review of the information you have provided. This response is not a classification decision for your device and does not constitute FDA clearance or approval for commercial distribution. Unless exempt from premarket notification submission (510(k)) requirements, the official classification for your device will appear on the final decision letter from any premarket review. All device types classified as exempt from the 510(k) requirements are subject to the limitations of exemptions. Limitations of device exemptions are found in the device classification chapters in 21 CFR xxx.9, where xxx refers to Parts 862-892 (e.g., 862.9, 864.9, etc.). Please be aware, if I have indicated that I believe your device falls within a device category classified as exempt from premarket review requirements, that it is your responsibility to ensure that you meet the exemption criteria and your device does not exceed the limitations of exemption. If your device exceeds the limitations of exemption, you must submit a 510(k) and receive a letter from FDA stating that your device may be commercially distributed in the U.S. prior to marketing your device.

This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.



Good morning,

I wanted to let you know we are aware of the sale of these type of lasers and laser pointers and are investigating the situation. As you know, these would still fall under 21 CFR 2040.11(b), limiting the output to 5 mW. We have consumer articles on the FDA website warning customers that such purchases may be seized by Customs.

Our website discusses Internet sales here: http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/AlertsandNotices/ucm116534.htm and high power laser pointers here: http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/LaserProductsandInstruments/ucm116373.htm

Bests!
Aileen I. Velez Cabassa, M.S.
Consumer Safety Officer
Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration (FDA)
Telephone: [phone]
Fax [phone]
[e-mail]

This response represents to the best of my judgment how the device should be regulated, solely based upon a review of the information you have provided. This response is not a classification decision for your device and does not constitute FDA clearance or approval for commercial distribution. Unless exempt from premarket notification submission (510(k)) requirements, the official classification for your device will appear on the final decision letter from any premarket review. All device types classified as exempt from the 510(k) requirements are subject to the limitations of exemptions. Limitations of device exemptions are found in the device classification chapters in 21 CFR xxx.9, where xxx refers to Parts 862-892 (e.g., 862.9, 864.9, etc.). Please be aware, if I have indicated that I believe your device falls within a device category classified as exempt from premarket review requirements, that it is your responsibility to ensure that you meet the exemption criteria and your device does not exceed the limitations of exemption. If your device exceeds the limitations of exemption, you must submit a 510(k) and receive a letter from FDA stating that your device may be commercially distributed in the U.S. prior to marketing your device.

This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.