PMA
P150034: Raindrop Near Vision Inlay
FDA PMA · Implant, corneal, refractive · Rvo 2.0, Inc. (D.B.A. Optics Medical)
Key facts
| PMA number | P150034 |
|---|---|
| Trade name | Raindrop Near Vision Inlay |
| Generic name | Implant, corneal, refractive |
| Applicant | Rvo 2.0, Inc. (D.B.A. Optics Medical) |
| Owner/operator | OPTICS INCORPORATED |
| Product code | LQE |
| Approval date | Jun 29, 2016 |
| Docket number | 16M-1837 |
| Notice date | Jul 8, 2016 |
| Establishment registration | 3017541416 |
| FEI number | 3017541416 |
At a glance
- 10–99 Supplements
- Jan 4, 2022 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- No Withdrawn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: