Data / Medical devices / Eyelid Thermal Pulsation System
Eyelid Thermal Pulsation System (ORZ): 14 FDA-registered makers in 4 countries
14 establishments in 4 countries are registered with the FDA to make Eyelid Thermal Pulsation System (product code ORZ, Class 2, 21 CFR 886.5200). 6 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on August 18, 2026, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- ORZ
- Device class
- 2
- Regulation
- 886.5200
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| China | 3 |
| Israel | 1 |
| Dominican Republic | 1 |
Makers of Eyelid Thermal Pulsation System
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 |
| Novoxel Ltd. | Netanya Tel Aviv, Israel | Manufacturer | 1 | November 4, 2024 | 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 | |
| Peter's Technology (suzhou) Co., Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Providence Enterprise Limited | Shenzhen Guangdong, China | 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 | |
| Remington Medical, S.A. | Santo Domingo Este, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Segue Xiamen Manufacturing Services, Inc | Xiamen Fujian, China | 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 August 18, 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.