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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceBLU -U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR
Generic NameSystem, laser, photodynamic therapy
ApplicantSun Pharmaceutical Industries, Inc.
29 Dunham Rd.
Billerica, MA 01821
PMA NumberP990019
Date Received03/16/1999
Decision Date12/03/1999
Product Code MVF 
Docket Number 00M-1613
Notice Date 11/14/2000
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S009 
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