# K053475: Optipoint Corneal Marker, Model VPT-Opt-450

- Pathway: 510(k) (Traditional)
- Applicant: Refractec, Inc.
- Decided: Mar 3, 2006 after 79 days
- Product code: HMR (Marker, Ocular)
- Device class: 1
- Regulation: 21 CFR 886.4570
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The OptiPoint Corneal Template is to be used in conjunction with a legally marketed skin marker to provide the location on the cornea for marking and subsequent ophthalmic surgical manipulation.

Source page: https://510kreport.com/device/K053475
Methodology: https://510kreport.com/methodology