TearCare MGX System - TearCare MGX Technology Kit

Basic Information

• Brand Name: TearCare MGX System - TearCare MGX Technology Kit
• Primary DI: 00858027006549
• Version / Model: FG 08789
• Catalog Number: 5-118
• Company Name: Sight Sciences, Inc.
• Labeler DUNS: 962750381
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-30
• Public Version: 1
• Public Version Date: 2025-05-08
• Public Version Status: New
• Public Device Record Key: 0c484f37-c867-4297-b15b-096acbf980e1

Device Description

TearCare MGX System - TearCare MGX Technology Kit including SmartHub, SmartHub Nest, and SmartCable

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ORZ	Eyelid Thermal Pulsation System	Ophthalmic	886.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62518	Eyelid heat therapy system control unit	An electrically-powered ophthalmic device intended to control the application of localized heat therapy to the outer eyelid surfaces of an adult patient during treatment of meibomian gland dysfunction (MGD), dry eye syndromes, blepharitis (inflammation of the eyelid), and other related ocular conditions. It is a portable unit intended to control the temperature applied to the eyelids via a skin surface applicator; the applicators are not included. It is intended to be used by a professional in a professional (e.g., clinical) setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858027006549	GS1

Premarket Submissions

Submission Number	Supplement Number
K242786	000

Storage Conditions

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