Identity
- Trade Name
- TearCare(TM) (2.2) System Kit FDA UDI
- Generic Name
- Eyelid heat therapy system control unit FDA UDI
- Device Name
- TearCare System Kit including the SmartHub Controller, Charging Cradle, IFU, and Charger Adapter FDA UDI
- Model / Reference
- FG 06041 FDA UDI
- Description
- TearCare System Kit including the SmartHub Controller, Charging Cradle, IFU, and Charger Adapter FDA UDI
Identifiers
- Catalog Number
- 5-100 FDA UDI
- Primary DI / UDI-DI
- 00858027006273 FDA UDI
- FDA Product Code
- IRT FDA UDI
- GMDN Term
- Eyelid heat therapy system control unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5740 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
TearCare(TM) (2.2) System Kit by Sight Sciences, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sight Sciences, Inc.
Sources (1)
- FDA UDI 65e9fe0a-f327-4e88-b0d9-6a43fd74c8b0 35 fields · synced Jun 9, 2026