PMA
P170035: Bausch + Lomb Ultra (samfilcon A) Contact Lenses
FDA PMA · Lenses, soft contact, extended wear · Bausch and Lomb, Inc.,
Key facts
| PMA number | P170035 |
|---|---|
| Trade name | Bausch + Lomb Ultra (samfilcon A) Contact Lenses |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Bausch and Lomb, Inc., |
| Owner/operator | Bausch & Lomb Incorporated |
| Product code | LPM |
| Approval date | Apr 30, 2018 |
| Docket number | 18M-1791 |
| Notice date | May 14, 2018 |
| Establishment registration | 1313525 |
| FEI number | 1317628 |
At a glance
- 10–99 Supplements
- Sep 14, 2026 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- No Withdrawn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: