BLU-U
FDA premarket approval P990019/S002 · decided 2003-01-09
Approval details
- PMA number
- P990019
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BLU-U
- Generic name
- System, laser, photodynamic therapy
- Applicant
- Sun Pharmaceutical Industries, Inc.
- Date received
- 2002-09-30
- Decision date
- 2003-01-09
- Days to decision
- 101 days
- Decision code
- APPR
- Product code
- MVF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Billerica, MA
- Statement
- APPROVAL FOR EXTENSION OF THE CALIBRATION INTERVAL FROM THE CURRENTLY APPROVED 500 CYCLES (WITH A 50 CYCLE BUFFER) TO 1600 CYCLES (WITH A 50 CYCLE BUFFER).
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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 |