PMA
P010061: CURELIGHT BROADBAND (MODEL CURELIGHT 01)
FDA PMA · System, non-coherent light, photodynamic therapy · Photocure Asa
Key facts
| PMA number | P010061 |
|---|---|
| Trade name | CURELIGHT BROADBAND (MODEL CURELIGHT 01) |
| Generic name | System, non-coherent light, photodynamic therapy |
| Applicant | Photocure Asa |
| Product code | MYH |
| Approval date | Jul 28, 2004 |
| Docket number | 04M-0345 |
| Notice date | Aug 4, 2004 |
At a glance
- None Supplements
- Jul 28, 2004 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: