LipiFlow Thermal Pulsation System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161357 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 LipiFlow Thermal Pulsation System is an electrically-powered eyelid thermal pulsation system intended for the application of localized heat and pressure therapy to the eyelids. It consists of a console and a single-use sterile device known as the Activator, and has a drug-free mechanism of action.
The system 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. It is supplied as a single-use sterile device and has received FDA 510(k) clearance under product code ORZ and regulation number 886.5200.
Frequently asked questions
What is the LipiFlow Thermal Pulsation System used for?
The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy to the eyelids in adult patients with chronic cystic conditions, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye. It treats gland blockage by combining controlled heat with pulsatile pressure to improve lipid secretion.
How is the LipiFlow System supplied and is it reusable?
The LipiFlow Thermal Pulsation System consists of a reusable console and a single-use sterile device called the Activator. The Activator is supplied sterile and is intended for one-time use only to prevent cross-contamination; the console is cleaned and reused between patients according to manufacturer instructions.
Does the LipiFlow System use drugs or have a drug-free mechanism?
The LipiFlow Thermal Pulsation System has a drug-free mechanism of action. It relies solely on the application of localized heat and pressure to the eyelids to liquefy and express obstructed meibum, without the use of pharmaceuticals or biologics in its operation.
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: LipiFlow® thermal pulsation system | J&J Vision Professional, PDF De Novo Classification Request for Tearscience Inc Lipiflow Thermal ..., LIPIFLOW THERMAL PULSATION SYSTEM by TEARSCIENCE, INC. | FDA 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161357 | Class II | Active |
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Manufacturer
- Manufacturer
- Tearscience, Inc.
Sources (1)
- FDA 510(k) K161357 24 fields · synced Oct 1, 2026