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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K241358
Device Name BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E
Applicant
Sun Pharmaceutical Industries, Inc.
29 Dunham Rd.
Billerica,  MA  01821
Applicant Contact Scott Lundahl
Correspondent
Sun Pharmaceutical Industries, Inc.
29 Dunham Rd.
Billerica,  MA  01821
Correspondent Contact Scott Lundahl
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/14/2024
Decision Date 06/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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