TearCare System – TearCare SmartHub Kit
TearCare System SmartHub Kit including SmartHub, charging nest, and charging adapter
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 | Sight Sciences, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K213045 |
| Record published | 2022-03-03 |
| Record revised | 2023-08-22 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FG 07392 | 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 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 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262479 | 2026-08-18 |
| K252409 | 2026-04-27 |
| K242786 | 2025-04-15 |
| K231084 | 2023-12-27 |
| K213045 | 2021-12-21 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2022-03-23 | Class II | No Marketing Application | Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the relevant 510(k) exemption and so their performance characteristics were not evaluated by the FDA prior to distribution. | 921 |
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.