TearCare MGX System
Sight Sciences, Inc.
SIGHT SCIENCES, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010363671 | 3010363671 | SIGHT SCIENCES, INC. | 1 | N | 2026-01-01 | 4040 Campbell Ave. Suite 100 Menlo Park CA US 94025 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 159562 | 1641243725 | K242786 | TearCare MGX System | ORZ | 2025-04-15 |
| 159562 | 1340855556 | K232214 | OMNI Surgical System | MRH | 2023-08-25 |
| 159562 | 1855643384 | K231084 | TearCare MGX System | ORZ | 2023-12-27 |
| 159562 | 1523996348 | K213045 | TearCare System | ORZ | 2021-12-21 |
| 159562 | 1581883624 | K202678 | OMNI Surgical System | MRH | 2021-03-01 |
| 159562 | 1852704312 | K173332 | OMNI Surgical System | MRH | 2017-12-21 |
| 159562 | 1625522649 | K171905 | VISCO 360 Viscosurgical System | MRH | 2017-07-27 |
| 159562 | 1426955064 | ||||
| 159562 | 1581352775 | ||||
| 159562 | 1923288050 | ||||
| 159562 | 1317268757 | ||||
| 159562 | 1744433551 |
Product Codes Associated With Registrations#
PMN#
TearCare MGX System
Sight Sciences, Inc.
OMNI Surgical System
Sight Sciences, Inc.
TearCare System
Sight Sciences, Inc.
OMNI Surgical System
Sight Sciences, Inc.
OMNI PLUS Surgical System
Sight Sciences, Inc.
OMNI Surgical System
Sight Sciences, Inc.
VISCO 360 Viscosurgical System
Sight Sciences, Inc.
Viscoelastic Injector
Sight Sciences, Inc.
VISCOELASTIC INJECTOR
SIGHT SCIENCES, INC.
GUDID#
OMNI(R) Surgical System (US) - OMNI System for US in a single pack
2020-06-01
TearCare MGX System - TearCare MGX Technology Kit - TearCare MGX System - TearCare MGX Technology Kit including SmartHub, SmartHub Nest, and SmartCable
2025-04-30
TearCare MGX System - TearCare MGX SmartLids - FG 08785
2025-04-29
OMNI Edge Surgical System - 1-112
2025-03-06
TearCare SmartLid - Eyelid heat therapy system applicator
2019-08-27
OMNI PLUS - OMNI PLUS Surgical System
2020-10-30
OMNI Surgical System - OMNI Surgical System, 21 uL
2023-10-17
TearCare(R) Clearance Assistant PLUS - TearCare Clearance Assistant PLUS
2023-08-22
TearCare(R) Clearance Assistant - Sterile - Forceps - Sterile
2018-04-23
OMNI Surgical System - OMNI Surgical System: Ergo series of revisions
2022-08-22
Sion Surgical Instrument - The Sight Sciences SION™ Surgical Instrument is a handheld, single use, sterile, bladeless surgical instrument.
2022-08-01
TearCare System - TearCare SmartHub Kit - TearCare System SmartHub Kit including SmartHub, charging nest, and charging adapter
2022-03-03
TearCare System - TearCare SmartLids - Eyelid heat therapy system applicator
2022-03-03
TearCare(TM) (2.2) System Kit - TearCare System Kit including the SmartHub Controller, Charging Cradle, IFU, and Charger Adapter
2019-08-27
TearCare iLid (TM) Device Packaged Pair - 10 pk - Eyelid heat therapy system applicator 10 pk
2018-03-16
OMNI Surgical System (US) - OMNI System for US in a single pack
2019-10-25
VISCO(TM)360 Viscosurgical System - US version of the Visco360
2016-09-22
TRAB(TM)360 Trabeculotomy System - US version of the TRAB360
2016-11-23
TearCare System - Eyelid heat therapy system control unit
2017-02-01
TearCare iLid Pair - Eyelid heat therapy system applicator
2017-02-01
TearCare(TM) System Kit - TearCare System Kit including the Controller, Charging Cradle, IFU, and Charger Adapter
2018-03-16
OMNI Surgical System (US) - Omni System for US in a single pack
2018-03-16
TearCare(TM) SmartLid (TM) (2.2) Packaged Pairs -10 pk - Eyelid heat therapy system applicator - 10 pk
2019-08-27
TearCare(R) Clearance Assistant - Sterile - 10 pk - Forceps - Sterile - 10 pack
2018-04-23