TearCare System – TearCare SmartLids
TearCare SmartLids are the single-use eyelid components of the TearCare System. The FDA filing says they conform to the upper and lower eyelid and connect to the SmartHub through a cable…
TearCare SmartLids are the single-use eyelid components of the TearCare System. The FDA filing says they conform to the upper and lower eyelid and connect to the SmartHub through a cable integrated into each SmartLid.
The filing describes SmartLids as carrying flexible circuits, sensors, and a microprocessor. During use, the system applies localized heat to the eyelids; the SmartLids are affixed to the external eyelid surface and removed after the procedure.
Component Connection
Each integrated cable is described as four feet long. The SmartHub is the reusable component that powers the SmartLids during treatment; the filing distinguishes these parts in its system component list.
Application
The filing describes applying flexible SmartLids to the external upper and lower eyelids. It says the SmartHub is turned on and the eye care professional initiates the procedure before heat delivery begins.
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 |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FG 07938 | 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 |
| 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.