# P210005: IC-8 Apthera Intraocular Lens (IOL)

- Pathway: PMA
- Applicant: Acu Focus, Inc.
- Decided: Jul 22, 2022 after 513 days
- Product code: POE (Extended Depth Of Focus Intraocular Lens)
- 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/P210005
Methodology: https://510kreport.com/methodology