PMA
P200020: SBL-3 Multifocal Intraocular Lens
FDA PMA · Lens, multifocal intraocular · Lenstec, Inc.
Key facts
| PMA number | P200020 |
|---|---|
| Trade name | SBL-3 Multifocal Intraocular Lens |
| Generic name | Lens, multifocal intraocular |
| Applicant | Lenstec, Inc. |
| Owner/operator | LENSTEC, INC. |
| Product code | MFK |
| Approval date | Jul 22, 2022 |
| Docket number | 22M-1754 |
| Notice date | Aug 2, 2022 |
| Establishment registration | 1063199 |
| FEI number | 3001659659 |
At a glance
- 10–99 Supplements
- Apr 15, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: