Identifiers
- 510(k) Number
- K242786 FDA 510(k)
- FDA Product Code
- ORZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.5200 FDA 510(k)
- Regulation Number
- 886.5200 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TearCare MGX System is an Eyelid Thermal Pulsation System designed to deliver localized heat therapy to the meibomian glands. It is intended for use in adult patients with evaporative dry eye disease caused by meibomian gland dysfunction (MGD), aiding in the expression of gland secretions. The device combines thermal activation with manual gland expression to improve gland function and reduce symptoms associated with MGD. Its classification under FDA’s Device Class II reflects its regulated status for therapeutic use in ophthalmic applications.
The TearCare MGX System is supplied as a reusable medical device, intended for use in professional eye care settings. It operates under FDA 510(k) clearance (K242786) and is classified under ORZ product code, adhering to 21 CFR Part 886.5200 regulations. The system requires no sterilization between uses in clinical environments but must be cleaned and maintained per manufacturer guidelines. Its design ensures compatibility with standard ophthalmic examination procedures, with no known MRI safety restrictions.
Frequently asked questions
What is the TearCare MGX System used for?
The TearCare MGX System is designed to treat evaporative dry eye disease caused by meibomian gland dysfunction (MGD) in adult patients. It uses localized heat therapy to activate the meibomian glands, helping to express gland secretions and improve gland function. This reduces symptoms like dryness, irritation, and blurred vision associated with MGD.
Is the TearCare MGX System reusable or single-use?
The TearCare MGX System is a reusable medical device intended for use in professional eye care settings. It does not require sterilization between uses but must be cleaned and maintained according to the manufacturer’s guidelines to ensure proper function and hygiene.
How is the TearCare MGX System different from other thermal therapy devices?
Unlike some thermal therapy devices that rely solely on heat, the TearCare MGX System combines thermal activation with manual gland expression. This dual-action approach is designed to enhance gland function more effectively, addressing the root cause of MGD-related dry eye symptoms. Its FDA 510(k) clearance (K242786) under the ORZ product code further distinguishes it as a regulated therapeutic device for ophthalmic use.
Does the TearCare MGX System require special storage or handling?
The device should be stored in a clean, dry environment when not in use, following the manufacturer’s maintenance instructions. While it does not require sterilization between clinical uses, proper cleaning is essential to prevent contamination and ensure longevity. The system is compatible with standard ophthalmic examination procedures and has no known MRI safety restrictions.
What regulatory approvals does the TearCare MGX System hold?
The TearCare MGX System holds FDA 510(k) clearance (K242786) and is classified under the ORZ product code, adhering to 21 CFR Part 886.5200 regulations. This clearance confirms its substantial equivalence to a predicate device and its intended use for treating MGD-related dry eye in adult patients.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF April 15, 2025 - accessdata.fda.gov, TearCare MGX System (K252409) — FDA 510 (k) | Innolitics, Sight Sciences Announces 1,000th TearCare® Customer Installation
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242786 | Class II | Active |
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Manufacturer
- Manufacturer
- Sight Sciences, Inc.
Sources (1)
- FDA 510(k) K242786 24 fields · synced Oct 1, 2026