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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBLU-U Blue Light Photodynamic Therapy Illuminator
Generic NameSystem, laser, photodynamic therapy
ApplicantSun Pharmaceutical Industries, Inc.
29 Dunham Rd.
Billerica, MA 01821
PMA NumberP990019
Supplement NumberS009
Date Received02/03/2025
Decision Date05/01/2025
Product Code MVF 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for BLU-U Model 4170E with light emitting diode (LED) light panels as a replacement for the BLU-U Model 4170 with fluorescent tubes.
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