# K182506: LipiScan Dynamic Meibomian Imager

- Pathway: 510(k) (Traditional)
- Applicant: Tearscience, Inc.
- Decided: Dec 10, 2018 after 89 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: 6 generations back to K913929 (1991). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152869: LipiView II Ocular Surface Interferometer, Tearscience, Inc. (2016) Summary page 4.

## Indications for use
LipiScan™ Dynamic Meibomian Imager is an ophthalmic imaging device intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of the meibomian glands.

Source page: https://510kreport.com/device/K182506
Methodology: https://510kreport.com/methodology