ORZ · Eyelid Thermal Pulsation System
Ophthalmic · 21 CFR 886.5200 · Class 2
Overview
| Product Code | ORZ |
|---|---|
| Device Name | Eyelid Thermal Pulsation System |
| Regulation | 21 CFR 886.5200 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
Identification
An eyelid thermal pulsation system is an electrically-powered device intended for use in the application of localized heat and pressure therapy to the eyelids. The device is used in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye. The system consists of a component that is inserted around the eyelids and a component to control the application of heat and pressure to the eyelids.
Classification Rationale
Class II (special controls). The special controls for this device are:
Special Controls
In addition to the general controls of the Act, the LipiFlow® Thermal Pulsation System is subject to the following special controls:
*Classification.* Class II (special controls). The special controls for this device are:(1) Appropriate analysis/testing should validate electromagnetic compatibility (EMC) and safety of exposure to non-ionizing radiation; (2) Design, description, and performance data should validate safeguards related to the temperature and pressure aspects of the device, including during fault conditions; (3) Performance data should demonstrate the sterility of patient-contacting components and the shelf-life of these components; (4) The device should be demonstrated to be biocompatible; and (5) Performance data should demonstrate that any technological changes do not adversely effect safety and effectiveness.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242786 | TearCare MGX System | Sight Sciences, Inc. | Apr 15, 2025 | SESE |
| K240512 | Tixel i (TXLI0001) | Novoxel , Ltd. | Nov 4, 2024 | SESE |
| K231084 | TearCare MGX System | Sight Sciences, Inc. | Dec 27, 2023 | SESE |
| K213045 | TearCare System | Sight Sciences, Inc. | Dec 21, 2021 | SESE |
| K200400 | Systane iLux2 | Tear Film Innovations, Inc. | May 21, 2020 | SESE |
| K192623 | LipiFlow Thermal Pulsation System | Tearscience, Inc. | Oct 22, 2019 | SESE |
| K172645 | iLux Instrument, iLux Disposable | Tear Film Innovations, Inc. | Dec 26, 2017 | SESE |
| K161357 | LipiFlow Thermal Pulsation System | Tearscience, Inc. | Nov 4, 2016 | SESE |
| K133127 | LIPIFLOW THERMAL PULSATION SYSTEM | Tearscience, Inc. | Dec 23, 2013 | SESE |
| K112704 | LIPIFLOW THERMAL PULSATION SYSTEM | Tearscience, Inc. | Dec 19, 2011 | SESE |
| DEN100017 | LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) | Tearscience, Inc. | Jun 28, 2011 | DENG |
Top Applicants
- Tearscience, Inc. — 5 clearances
- Sight Sciences, Inc. — 3 clearances
- Tear Film Innovations, Inc. — 2 clearances
- Novoxel , Ltd. — 1 clearance
