# K111771: Non-Contact Tear Film Thermogragh

- Pathway: 510(k) (Traditional)
- Applicant: United Integrated Services Co., Ltd.
- Decided: Nov 30, 2011 after 160 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.
1 later device descends from it; 1 cites it directly.
0 of 8 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
- K253176: TearView (2026), 0 descendants of its own

## Indications for use
The UIS Non-Contact Thermograph System is an ophthalmic imaging device that stores, archives, and manipulates digital images of ocular surface temperature measurements taken by a physician in adult patients.

Source page: https://510kreport.com/device/K111771
Methodology: https://510kreport.com/methodology