BLU-U Blue Light Photodynamic Therapy Illuminator
FDA premarket approval P990019/S009 · decided 2025-05-01
Approval details
- PMA number
- P990019
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BLU-U Blue Light Photodynamic Therapy Illuminator
- Generic name
- System, laser, photodynamic therapy
- Applicant
- Sun Pharmaceutical Industries, Inc.
- Date received
- 2025-02-03
- Decision date
- 2025-05-01
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- MVF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Billerica, MA
- 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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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E (K241358) | Sun Pharmaceutical Industries, Inc. | 2024-06-13 |