# K132042: AMB101 System, Amblyz, LCG System, Xpand

- Pathway: 510(k) (Traditional)
- Applicant: X6d, Ltd.
- Decided: Apr 28, 2014 after 300 days
- Product code: HOY (Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear))
- Device class: 1
- Regulation: 21 CFR 886.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K050856 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050856: LCG (Liquide Crystal Glasses) System, Ophthocare, Ltd. (2005) Summary page 1.

## Indications for use
The AmblyzTM System is an electronic shutter module intended to provide occlusions of the eye in an intermittent fashion.

Source page: https://510kreport.com/device/K132042
Methodology: https://510kreport.com/methodology