TearCare(TM) System Kit 5-100

GUDID 00858027006242

TearCare System Kit including the Controller, Charging Cradle, IFU, and Charger Adapter

SIGHT SCIENCES, INC.

Eyelid heat therapy system control unit

• Primary Device ID: 00858027006242
• NIH Device Record Key: 8cb51158-64ea-46d8-963d-28f7473bac29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TearCare(TM) System Kit
• Version Model Number: FG 05509
• Catalog Number: 5-100
• Company DUNS: 962750381
• Company Name: SIGHT SCIENCES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858027006242 [Primary]

FDA Product Code

• IRT: Pad, Heating, Powered

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: 2018-04-16
• Device Publish Date: 2018-03-16

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: 2025-05-07 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