PMA P990019S009

Device: BLU-U Blue Light Photodynamic Therapy Illuminator
Applicant: Sun Pharmaceutical Industries, Inc.
PMA number: P990019
Supplement: S009
Product code: MVF
Decision date: 2025-05-01
Classification: General, Plastic Surgery
Generic name: System, laser, photodynamic therapy
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.

Current openFDA PMA Record#

Device: BLU-U Blue Light Photodynamic Therapy Illuminator
Applicant: Sun Pharmaceutical Industries, Inc.
PMA number: P990019
Supplement: S009
Product code: MVF
Generic name: System, laser, photodynamic therapy
Decision date: 2025-05-01
Decision code: APPR
Date received: 2025-02-03
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.