# P160055: Light Adjustable Lens (Lal) and Light Delivery Device (LDD)

- Pathway: PMA
- Applicant: Rxsight, Inc.
- Decided: Nov 22, 2017 after 348 days
- Product code: PZK (Light Adjustable Lens (Lal) And Light Delivery Device (Ldd))
- Device class: 3
- Regulation: 21 CFR 886.3600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P160055
Methodology: https://510kreport.com/methodology