LipiView II Ocular Surface Interferometer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K152869 FDA 510(k)
- FDA Product Code
- HKI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1120 FDA 510(k)
- Regulation Number
- 886.1120 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The LipiView II Ocular Surface Interferometer is an ophthalmic camera, AC-powered device used for imaging the lipid layer of the tear film, meibomian glands, ocular surface, and eyelids. It utilizes interferometry technology to assess factors contributing to dry eye disease.
This bench-top device is supplied as a reusable system and was cleared by the FDA via the 510(k) pathway on January 14, 2016, under K152869. It is intended for use in clinical settings to support diagnosis and patient education regarding ocular health.
Frequently asked questions
What is the LipiView II Ocular Surface Interferometer used for?
The LipiView II Ocular Surface Interferometer is used to image the lipid layer of the tear film, meibomian glands, ocular surface, and eyelids using interferometry technology to assess factors contributing to dry eye disease, supporting diagnosis and patient education in clinical settings.
How is the LipiView II device supplied and powered?
The LipiView II is supplied as a reusable bench-top system and is AC-powered, designed for use in clinical environments to support ocular surface evaluation.
What regulatory pathway was used for the LipiView II clearance?
The LipiView II Ocular Surface Interferometer was cleared by the FDA via the 510(k) pathway on January 14, 2016, under submission number K152869, and is classified as a Class II device.
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: LipiView® II ocular surface interferometer | J&J Vision Pro, Interferometry dry eye diagnosis system - LipiView II - TearScience ..., PDF LipiView II 510k - Sept 2015 - Food and Drug Administration, LipiView II Ocular Surface Interferometer - Tearscience | FDA Evidence ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152869 | Class II | Active |
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Manufacturer
- Manufacturer
- Tearscience, Inc.
Sources (1)
- FDA 510(k) K152869 24 fields · synced Sep 25, 2026