TearCare MGX System – TearCare MGX Technology Kit
The TearCare MGX Technology Kit contains the reusable SmartHub controller, SmartCable and charging equipment for in-office eyelid heat therapy. Used with separate SmartLids, it supports…
The TearCare MGX Technology Kit contains the reusable SmartHub controller, SmartCable and charging equipment for in-office eyelid heat therapy. Used with separate SmartLids, it supports treatment of adults with evaporative dry eye due to meibomian gland dysfunction, together with manual gland expression.
An eye care practitioner connects the eyelid-mounted SmartLids to the SmartHub using the cable and starts the session. The hub monitors and controls lid temperature through a 15-minute heating cycle, ramping from 41 to 45 degrees Celsius and signaling completion visually and audibly.
Listed Item
TearCare MGX System – TearCare MGX Technology Kit including SmartHub, SmartHub Nest, and SmartCable
Warming Hold
An optional hold maintains 41 degrees Celsius for up to 10 additional minutes while the practitioner prepares to express the glands. Heat stops when a SmartLid is removed or treatment is paused or stopped. Manual expression uses separately available forceps.
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) | K242786 |
| Record published | 2025-04-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment temperature -20 to 55 °C; Storage environment humidity 15 to 95 % RH; Storage environment atmospheric pressure 50 to 107 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FG 08789 | 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 |
| Lipiflow System Console | TearScience, 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.