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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.
 
DeviceBLU -U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR
Classification Namesystem, laser, photodynamic therapy
Generic Namesystem, laser, photodynamic therapy
Applicant
DUSA PHARMACEUTICALS, INC.
25 upton dr.
wilmington, MA 01887
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 
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