21 CFR 886.5200 — Eyelid Thermal Pulsation System
Ophthalmic (OP) · Part 886 Subpart F—Therapeutic Devices · § 886.5200
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:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ORZ | Eyelid Thermal Pulsation System | 2 | 11 |
Special Controls
ORZ — Eyelid Thermal Pulsation System
In addition to the general controls of the Act, the LipiFlow® Thermal Pulsation System is subject to the following special controls:
De Novo Order DEN100017
ORZ — Eyelid Thermal Pulsation System
*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.
eCFR
ORZ — Eyelid Thermal Pulsation System
(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.
Ecfr Llm
