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TearCare System - TearCare SmartHub Kit

FDA UDI

Class II (US FDA UDI)

by Sight Sciences, Inc.

Identity

Trade Name
TearCare System - TearCare SmartHub Kit FDA UDI
Generic Name
Eyelid heat therapy system control unit FDA UDI
Device Name
TearCare System SmartHub Kit including SmartHub, charging nest, and charging adapter FDA UDI
Model / Reference
FG 07392 FDA UDI
Description
TearCare System SmartHub Kit including SmartHub, charging nest, and charging adapter FDA UDI

Identifiers

Catalog Number
5-116 FDA UDI
Primary DI / UDI-DI
00858027006457 FDA UDI
510(k) Number
K213045 FDA UDI
FDA Product Code
ORZ FDA UDI
GMDN Term
Eyelid heat therapy system control unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.5200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Eyelid heat therapy system control unit

TearCare System - TearCare SmartHub Kit by Sight Sciences, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Eyelid heat therapy system control unit.

Cleared under the same submission

K213045 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sight Sciences, Inc.

Sources (1)

  • FDA UDI 1a811121-a176-44b8-b119-458e532da73a 35 fields · synced Jun 9, 2026