PMA
P050026: QUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS
FDA PMA · System, laser, photodynamic therapy · Bausch + Lomb Ireland Limited
Key facts
| PMA number | P050026 |
|---|---|
| Trade name | QUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS |
| Generic name | System, laser, photodynamic therapy |
| Applicant | Bausch + Lomb Ireland Limited |
| Owner/operator | Bausch Health US LLC |
| Product code | MVF |
| Approval date | Apr 4, 2006 |
| Docket number | 06M-0162 |
| Notice date | Apr 18, 2006 |
| Establishment registration | 3009443653 |
| FEI number | 3009443653 |
At a glance
- 1–9 Supplements
- Feb 11, 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- No Withdrawn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: