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 Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit Eyelid heat therapy system control unit 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