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          Laser Energy Source (Laser Notice 2)Search for FDA Guidance Documents GUIDANCE DOCUMENT
	Laser Energy Source (Laser Notice 2)
					
		
		November 1975


	Download the  Final Guidance Document 

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    PrintDocket Number:
		    FDA-2020-D-0957
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Devices and Radiological Health


ADVISORY OPINION: The electron beam accelerator, as a laser energy source, does not meet the criteria for a laser product as defined in paragraph 1040.lO(b)(17). Therefore, it would not be subject separately to 21 CFR 1040.10 and 1040.11.


 
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                                                                                  Content current as of:
      08/24/2018
         
                  
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