Identity
- Trade Name
- TearCare MGX System - TearCare MGX SmartLids FDA UDI
- Generic Name
- Eyelid heat therapy system applicator FDA UDI
- Device Name
- TearCare MGX System - TearCare MGX SmartLids FDA UDI
- Model / Reference
- FG 08785 FDA UDI
- Description
- TearCare MGX System - TearCare MGX SmartLids FDA UDI
Identifiers
- Catalog Number
- 5-109 FDA UDI
- Primary DI / UDI-DI
- 00858027006297 FDA UDI
- 510(k) Number
- K242786 FDA UDI
- FDA Product Code
- ORZ FDA UDI
- GMDN Term
- Eyelid heat therapy system applicator 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Eyelid heat therapy system applicator
TearCare MGX System - TearCare MGX SmartLids 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 applicator.
- TearCare System - TearCare SmartLids — Sight Sciences, Inc. · Class II
Cleared under the same submission
K242786 also covers:
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 9a1c3c88-2c4c-49c6-bd08-45656f7bfb68 36 fields · synced Jun 9, 2026