TearCare MGX System - TearCare MGX SmartLids 5-109

GUDID 00858027006297

TearCare MGX System - TearCare MGX SmartLids

Sight Sciences, Inc.

Eyelid heat therapy system applicator

• Primary Device ID: 00858027006297
• NIH Device Record Key: 9a1c3c88-2c4c-49c6-bd08-45656f7bfb68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TearCare MGX System - TearCare MGX SmartLids
• Version Model Number: FG 08785
• Catalog Number: 5-109
• Company DUNS: 962750381
• Company Name: Sight Sciences, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858027006297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242786

FDA Product Code

• ORZ: Eyelid Thermal Pulsation System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-07
• Device Publish Date: 2025-04-29

Devices Manufactured by Sight Sciences, Inc.

• 00858027006549 - TearCare MGX System - TearCare MGX Technology Kit: 2025-05-08 TearCare MGX System - TearCare MGX Technology Kit including SmartHub, SmartHub Nest, and SmartCable
• 00858027006297 - TearCare MGX System - TearCare MGX SmartLids: 2025-05-07TearCare MGX System - TearCare MGX SmartLids
• 00858027006297 - TearCare MGX System - TearCare MGX SmartLids: 2025-05-07 TearCare MGX System - TearCare MGX SmartLids
• 00858027006594 - OMNI Edge Surgical System: 2025-03-14 OMNI Edge Surgical System
• 00858027006433 - OMNI Surgical System: 2023-10-25 OMNI Surgical System, 21 uL
• 00858027006389 - TearCare(R) Clearance Assistant PLUS: 2023-08-30 TearCare Clearance Assistant PLUS
• 00858027006280 - TearCare SmartLid: 2023-08-22 Eyelid heat therapy system applicator
• 00858027006266 - TearCare(R) Clearance Assistant - Sterile: 2023-08-04 Forceps - Sterile
• 00858027006525 - OMNI Surgical System: 2022-08-30 OMNI Surgical System: Ergo series of revisions