PMA
P990078: HYPERION LTK SYSTEM
FDA PMA · Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary · Sunrise Technologies, Inc.
Key facts
| PMA number | P990078 |
|---|---|
| Trade name | HYPERION LTK SYSTEM |
| Generic name | Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary |
| Applicant | Sunrise Technologies, Inc. |
| Owner/operator | SUNRISE |
| Product code | LOI |
| Approval date | Jun 30, 2000 |
| Docket number | 00M-1386 |
| Notice date | Jul 11, 2000 |
| Establishment registration | 3022505448 |
| FEI number | 3022505448 |
At a glance
- 1–9 Supplements
- May 8, 2002 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- No Withdrawn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: