Lipiflow System Console
Assembly Pkgd Lipiflow - US
4manufacturers in China registered for this device type
1catalogue number
5510(k) clearances naming this product code
2recalls on this code
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 | TearScience, Inc., United States |
|---|---|
| FDA product code | ORZ |
| Device type | Eyelid Thermal Pulsation System |
| Device class | Class 2 |
| Regulation | 21 CFR 886.5200 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2025-01-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 10 to 40 °C |
| Sizes | Pressure 6 psi |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LFTP-1000 | Pressure 6 psi | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| iLux | Alcon Laboratories, Inc. | 4 |
| 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 |
| TearCare MGX System – TearCare MGX Technology Kit | Sight Sciences, Inc. | 1 |
| Lipiflow System Activator II Cable KIT | TearScience, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192623 | 2019-10-22 |
| K161357 | 2016-11-04 |
| K133127 | 2013-12-23 |
| K112704 | 2011-12-19 |
| DEN100017 | 2011-06-28 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-01-30 | Class II | Labeling Change Control | Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration. | 94,095 units. | 2017-11-27 |
| 2016-09-13 | Class II | Device Design | Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator. | 1,200 Activators (120 boxes of 10 units) | 2017-02-09 |
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.