Data / Medical devices / Eyelid Thermal Pulsation System / United States
FDA-registered makers of Eyelid Thermal Pulsation System in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Eyelid Thermal Pulsation System (product code ORZ). 5 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Eyelid Thermal Pulsation System
- Product code
- ORZ
- Country
- United States
Makers of Eyelid Thermal Pulsation System in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Sight Sciences, Inc. | Menlo Park, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 4 | August 18, 2026 | 0 | 1 | 0 | api.fda.gov |
| Alcon Research, LLC | Irvine, CA, United States | Manufacturer | 2 | May 21, 2020 | 0 | 0 | 0 | api.fda.gov |
| Alcon Research, LLC | Fort Worth, TX, United States | Specification developer | 2 | May 21, 2020 | 0 | 0 | 0 | api.fda.gov |
| TearScience, Inc. | Milpitas, CA, United States | Manufacturer, Specification developer | 2 | October 22, 2019 | 0 | 2 | 0 | api.fda.gov |
| Alcon Research, LLC | Lake Forest, CA, United States | Specification developer | 1 | May 21, 2020 | 0 | 0 | 0 | api.fda.gov |
| Evolve Manufacturing Technologies Inc. | Fremont, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MME Willow Lake | Vadnais Hts, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phillips-Medisize Costa Mesa LLC | Costa Mesa, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spartronics Strongsville, Inc. | Strongsville, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.