Identifiers
- 510(k) Number
- K213045 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 System is an Eyelid Thermal Pulsation System. It is classified as a Class II medical device under regulation number 886.5200 and is intended for use in ophthalmic applications.
The device is supplied as a reusable system and has received FDA 510(k) clearance (K213045). It is manufactured by Sight Sciences, Inc. and is used for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland disease.
Frequently asked questions
What is the TearCare System used for?
The TearCare System is an Eyelid Thermal Pulsation System intended for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland disease.
Is the TearCare System reusable or single-use?
The TearCare System is supplied as a reusable system, designed for multiple patient applications under proper sterilization protocols as specified by the manufacturer.
What regulatory approvals does the TearCare System have?
The TearCare System has received FDA 510(k) clearance (K213045) and is classified as a Class II medical device under regulation number 886.5200 for ophthalmic applications.
How is the TearCare System supplied?
The TearCare System is supplied as a complete reusable system that includes all necessary components for the application of localized heat therapy to treat evaporative dry eye disease.
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: Sight Sciences Announces Recognition of the TearCare® System in TFOS ..., Sight Sciences Receives FDA 510(k) Clearance of the TearCare® System ..., Sight Science's TearCare System earns spot in TFOS DEWS III dry eye ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213045 | Class II | Active |
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Manufacturer
- Manufacturer
- Sight Sciences, Inc.
Sources (1)
- FDA 510(k) K213045 24 fields · synced Sep 22, 2026