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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameBLU -U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR
Classification Namesystem, laser, photodynamic therapy
ApplicantDUSA PHARMACEUTICALS, INC.
PMA NumberP990019
Date Received03/16/1999
Decision Date12/03/1999
Product Code
MVF[ Registered Establishments with MVF ]
Docket Number 00M-1613
Notice Date 11/14/2000
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
The devices is indicated for use in photodynamic therapy with levulan kerastick (aminolevulinic acid hcl) for topical solution, 20% for the treatment of non-hyperkeratotic actinic keratoses of the face or scalp.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 
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