# K170761: LIGHTSonic BUBM

- Pathway: 510(k) (Traditional)
- Applicant: Lightmed USA, Inc.
- Decided: Apr 13, 2018 after 396 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: 3 generations back to K843696 (1985). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140199: VUPAD, Sonomed, Inc. (2014) Summary page 4.

## Most influential descendants
- K183173: LIGHTMED Ultrasound System (2019), 0 descendants of its own

## Indications for use
LIGHTSonic B∣UBM is a non-invasion diagnostic ophthalmic ultrasound instrument specifically designed for measurements inside the ocular structures including orbital, anterior and posterior segment of eye.

Source page: https://510kreport.com/device/K170761
Methodology: https://510kreport.com/methodology