BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR
FDA premarket approval P990019/S006 · decided 2009-01-09
Approval details
- PMA number
- P990019
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR
- Generic name
- System, laser, photodynamic therapy
- Applicant
- Sun Pharmaceutical Industries, Inc.
- Date received
- 2008-12-10
- Decision date
- 2009-01-09
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MVF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Billerica, MA
- Statement
- USE OF AN UPDATED MODEL OF THE TIMER ASSEMBLY USED IN THE DEVICE.
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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 |