FDA device listing
FIXED PD TRIAL FRAME,TRIAL CLIP (Janelli/Halberg)
FDA device listing 1319613654 · S4OPTIK LLC
Key facts
| Proprietary names | FIXED PD TRIAL FRAME,TRIAL CLIP (Janelli/Halberg) |
|---|---|
| Owner/operator | S4OPTIK LLC |
| Owner/operator number | 9077083 |
| Product codes | HPA |
| Device names | HPA - Frame, Trial, Ophthalmic |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.1415 |
| Review panels | Ophthalmic |
| Registered establishments | S4OPTIK LLC |
| Establishment registrations | 3004441848 |
| FEI numbers | 3004441848 |
| Establishment operations | Complaint File Establishment |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database