# K122481: Lipiview Ocular Surface Interferometer

- Pathway: 510(k) (Traditional)
- Applicant: Tearscience, Inc.
- Decided: Dec 31, 2012 after 139 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: 4 generations back to K913929 (1991). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 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 1.

## Most influential descendants
- K152869: LipiView II Ocular Surface Interferometer (2016), 1 descendant of its own
- K182506: LipiScan Dynamic Meibomian Imager (2018), 0 descendants of its own

## Indications for use
The LipiView® Ocular Surface Interferometer is an ophthalmic imaging device that is 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, which can be visually monitored and photographically documented. Using these images, the LipiView® Interferometer measures the absolute thickness of the tear film lipid layer.

Source page: https://510kreport.com/device/K122481
Methodology: https://510kreport.com/methodology