PMA
P050021: CERALAS I LASER
FDA PMA · System, laser, photodynamic therapy · Biolitec, Inc.
Key facts
| PMA number | P050021 |
|---|---|
| Trade name | CERALAS I LASER |
| Generic name | System, laser, photodynamic therapy |
| Applicant | Biolitec, Inc. |
| Product code | MVF |
| Approval date | Dec 20, 2005 |
| Docket number | 06M-0161 |
| Notice date | Apr 18, 2006 |
| FEI number | 1000120892 |
At a glance
- None Supplements
- Dec 20, 2005 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- Yes Withdrawn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: