PMA
P990019: BLU -U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR
FDA PMA · System, laser, photodynamic therapy · Sun Pharmaceutical Industries, Inc.
Key facts
| PMA number | P990019 |
|---|---|
| Trade name | BLU -U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR |
| Generic name | System, laser, photodynamic therapy |
| Applicant | Sun Pharmaceutical Industries, Inc. |
| Product code | MVF |
| Approval date | Dec 3, 1999 |
| Docket number | 00M-1613 |
| Notice date | Nov 14, 2000 |
| FEI number | 3002513708 |
At a glance
- 1–9 Supplements
- May 1, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: