Ilux
Systane iLux2 Meibography Tip
4manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Fujian (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Providence Enterprise Limited | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Segue Xiamen Manufacturing Services, Inc | Xiamen | Fujian | Contract manufacturer | 1 |
| Shenzhen JPY ION-Tech. Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
Record
| Listed by | Alcon Laboratories, Inc., United States |
|---|---|
| FDA product code | ORZ |
| Device type | Eyelid Thermal Pulsation System |
| Device class | Class 2 |
| Regulation | 21 CFR 886.5200 |
| 510(k) | K172645 |
| Record published | 2026-03-13 |
| Record revised | 2025-01-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Box of 3, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2022 | In distribution | |
| 2020 | In distribution | |
| 2022-PT | In distribution | |
| 2020-D | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lipiflow System Activator (Disposable) | TearScience, Inc. | 2 |
| Tearscience Activator Clear | Johnson & Johnson Surgical Vision, Inc. | 2 |
| TearCare System – TearCare SmartHub Kit | Sight Sciences, Inc. | 1 |
| TearCare MGX System – TearCare MGX SmartLids | Sight Sciences, Inc. | 1 |
| Lipiflow System Activator II (Disposable | TearScience, Inc. | 1 |
| Tixel i | Novoxel Ltd. | 1 |
| TearCare System – TearCare SmartLids | Sight Sciences, Inc. | 1 |
| Tixel i HP | Novoxel Ltd. | 1 |
| Lipiflow System Console | TearScience, Inc. | 1 |
| TearCare MGX System – TearCare MGX Technology Kit | Sight Sciences, Inc. | 1 |
| Lipiflow System Activator II Cable KIT | TearScience, Inc. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.