TearCare System - TearCare SmartHub Kit 5-116

GUDID 00858027006457

TearCare System SmartHub Kit including SmartHub, charging nest, and charging adapter

SIGHT SCIENCES, INC.

Eyelid heat therapy system control unit

• Primary Device ID: 00858027006457
• NIH Device Record Key: 1a811121-a176-44b8-b119-458e532da73a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TearCare System - TearCare SmartHub Kit
• Version Model Number: FG 07392
• Catalog Number: 5-116
• Company DUNS: 962750381
• Company Name: SIGHT SCIENCES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	00858027006457 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213045

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: 2022-03-11
• Device Publish Date: 2022-03-03

Devices Manufactured by SIGHT SCIENCES, INC.

• 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
• 00858027006501 - Sion Surgical Instrument: 2022-08-09 The Sight Sciences SION™ Surgical Instrument is a handheld, single use, sterile, bladeless surgical instrument.
• 00858027006457 - TearCare System - TearCare SmartHub Kit: 2022-03-11TearCare System SmartHub Kit including SmartHub, charging nest, and charging adapter
• 00858027006457 - TearCare System - TearCare SmartHub Kit: 2022-03-11 TearCare System SmartHub Kit including SmartHub, charging nest, and charging adapter
• 00858027006495 - TearCare System - TearCare SmartLids: 2022-03-11 Eyelid heat therapy system applicator