PMA
P010018: VIEWPOINT(TM) CK SYSTEM
FDA PMA · Electrosurgical, radio frequency, refractive correction · Refractec, Inc.
Key facts
| PMA number | P010018 |
|---|---|
| Trade name | VIEWPOINT(TM) CK SYSTEM |
| Generic name | Electrosurgical, radio frequency, refractive correction |
| Applicant | Refractec, Inc. |
| Product code | MWD |
| Approval date | Apr 11, 2002 |
| Docket number | 02M-0174 |
| Notice date | Apr 25, 2002 |
| FEI number | 3003804564 |
At a glance
- 10–99 Supplements
- Apr 6, 2006 Latest supplement decision
- No Withdrawn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: