# K183173: LIGHTMED Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Lightmed USA, Inc.
- Decided: Jul 1, 2019 after 227 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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 K843696 (1985). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170761: LIGHTSonic BUBM, Lightmed USA, Inc. (2018) Summary page 4.

## Indications for use
LIGHTMED Ultrasound System is a non-invasion diagnostic ophthalmic ultrasound instrument specifically designed for measurements inside the ocular structures including orbital, anterior, posterior segment of eye and axial length for determination of IOL Power.

Source page: https://510kreport.com/device/K183173
Methodology: https://510kreport.com/methodology