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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceBLU-U BLUE LIGHT PHOTODYNAMIC THERAPHY ILLUMINATOR
Classification Namesystem, laser, photodynamic therapy
Generic Namesystem, laser, photodynamic therapy
Applicant
DUSA PHARMACEUTICALS, INC.
25 upton dr.
wilmington, MA 01887
PMA NumberP990019
Supplement NumberS001
Date Received03/20/2000
Decision Date09/26/2000
Product Code
MVF[ Registered Establishments with MVF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the modified version of the blu-u(tm) blue light photodynamic therapy illuminator. The device, as modified, will be marketed under the trade name blu-u(tm) model 4170.
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