# K013756: Alphacor; Alphacor-a (for Ahakic Eyes); Alphacor-P (for Phakic or Pseudophakic Eyes)

- Pathway: 510(k) (Traditional)
- Applicant: Argus Biomedical Pty, Ltd.
- Decided: Aug 29, 2002 after 289 days
- Product code: HQM (Keratoprosthesis, Permanent Implant)
- Device class: 2
- Regulation: 21 CFR 886.3400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dohlman Doane Type I Keratoprosthesis: named in the summary without a submission number

## Most influential descendants
- K053298: Alphasphere Orbital Implant (2006), 0 descendants of its own

## Indications for use
Adult patients with corneal opacity not suitable for standard penetrating keratoplasty.,with donor tissues, or where donor tissue has been declined, or where adjunctive measures required to prevent graft rejection are medically contraindicated.

Source page: https://510kreport.com/device/K013756
Methodology: https://510kreport.com/methodology