# K152869: LipiView II Ocular Surface Interferometer

- Pathway: 510(k) (Traditional)
- Applicant: Tearscience, Inc.
- Decided: Jan 14, 2016 after 106 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K913929 (1991). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091935: Lipiview Ocular Surface Interferometer, Tearscience, Inc. (2009) Summary page 4.
- K122481: Lipiview Ocular Surface Interferometer, Tearscience, Inc. (2012) Summary page 4.
- K132186: Optomed Smartscope M5 / Optomed Smartscope EY4 / Optomed Smartscope ES2, Optomed OY (2013) Summary page 4.

## Most influential descendants
- K182506: LipiScan Dynamic Meibomian Imager (2018), 0 descendants of its own

## Indications for use
The LipiView II Ocular Surface Interferometer is an ophthalmic imaging device intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of: • Specular (interferometric) observations of the tear film. Using these images, LipiView® II measures the absolute thickness of the tear film lipid layer. • Meibomian glands under near-infrared (NIR) illumination • The ocular surface and eyelids under white illumination All of these image types can be photographically documented and visually monitored.

Source page: https://510kreport.com/device/K152869
Methodology: https://510kreport.com/methodology