# P120023: Kamra Inlay

- Pathway: PMA
- Applicant: Corneagen
- Decided: Apr 17, 2015 after 856 days
- Product code: LQE (Implant, Corneal, Refractive)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Feb 11, 2016 · Class II · Z-1235-2016: AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life.

Source page: https://510kreport.com/device/P120023
Methodology: https://510kreport.com/methodology