Atlas FDA

BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E

FDA 510(k) clearance K241358 · decided 2024-06-13

Clearance details

K-number
K241358
Device name
BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E
Applicant
Sun Pharmaceutical Industries, Inc.
Decision
Substantially Equivalent
Date received
2024-05-14
Decision date
2024-06-13
Days to decision
30 days
Clearance type
Special
Product code
GEX
Device class
2
Regulation number
878.4810
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Billerica, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
BLU-U Blue Light Photodynamic Therapy Illuminator (P990019/S009)Sun Pharmaceutical Industries, Inc.2025-05-01
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR (P990019/S007)Sun Pharmaceutical Industries, Inc.2011-07-07
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR (P990019/S006)Sun Pharmaceutical Industries, Inc.2009-01-09
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR, MODEL 4170 (P990019/S005)Sun Pharmaceutical Industries, Inc.2008-10-10
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR (P990019/S004)Sun Pharmaceutical Industries, Inc.2006-09-21
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR, MODEL 4170 (P990019/S003)Sun Pharmaceutical Industries, Inc.2005-10-06
BLU-U (P990019/S002)Sun Pharmaceutical Industries, Inc.2003-01-09
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPHY ILLUMINATOR (P990019/S001)Sun Pharmaceutical Industries, Inc.2000-09-26