# K091935: Lipiview Ocular Surface Interferometer

- Pathway: 510(k) (Traditional)
- Applicant: Tearscience, Inc.
- Decided: Oct 23, 2009 after 115 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: 3 generations back to K913929 (1991). 5 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980295: Ophthavision Imaging System, Mrp Group, Inc. (1998) Summary page 1.
- K973064: Keeler Tearscope-Plus, Keeler Instruments, Inc. (1998) Summary page 1.

## Most influential descendants
- K122481: Lipiview Ocular Surface Interferometer (2012), 2 descendants of its own
- K152869: LipiView II Ocular Surface Interferometer (2016), 1 descendant of its own
- K111771: Non-Contact Tear Film Thermogragh (2011), 1 descendant of its own
- K253176: TearView (2026), 0 descendants of its own
- K190573: KOWA DR-1a (2019), 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.

Source page: https://510kreport.com/device/K091935
Methodology: https://510kreport.com/methodology