Catalog Number

5-116

Brand Name

TearCare System - TearCare SmartHub Kit

Version/Model Number

FG 07392

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K213045

Product Code

ORZ

Product Code Name

Eyelid Thermal Pulsation System

Public Device Record Key

1a811121-a176-44b8-b119-458e532da73a

Public Version Date

March 11, 2022

Public Version Number

1

DI Record Publish Date

March 03, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-