BLU -U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR
FDA premarket approval P990019 · decided 1999-12-03
Approval details
- PMA number
- P990019
- Trade name
- BLU -U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR
- Generic name
- System, laser, photodynamic therapy
- Applicant
- Sun Pharmaceutical Industries, Inc.
- Date received
- 1999-03-16
- Decision date
- 1999-12-03
- Days to decision
- 262 days
- Decision code
- APPR
- Product code
- MVF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Billerica, MA
- Statement
- The devices is indicated for use in Photodynamic Therapy with Levulan Kerastick (aminolevulinic acid HCl) for Topical Solution, 20% for the treatment of non-hyperkeratotic actinic keratoses of the face or scalp.
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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 |