FDA device listing
TearCare System - TearCare SmartHub Kit
FDA device listing 1608277131 · EVOLVE MANUFACTURING TECHNOLOGIES INC.
Key facts
| Proprietary names | TearCare System - TearCare SmartHub Kit |
|---|---|
| Owner/operator | EVOLVE MANUFACTURING TECHNOLOGIES INC. |
| Owner/operator number | 9100955 |
| Product codes | ORZ |
| Device names | ORZ - Eyelid Thermal Pulsation System |
| Device class | Class II |
| Classification regulations (21 CFR) | 886.5200 |
| Review panels | Ophthalmic |
| Registered establishments | EVOLVE MANUFACTURING TECHNOLOGIES INC. |
| Establishment registrations | 3006262888 |
| FEI numbers | 3006262888 |
| Establishment operations | Contract Manufacturer |
| 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