510(k) Report

510(k) · Cleared

Cleared

Optipoint Corneal Marker, Model VPT-Opt-450

K053475510(k) TraditionalCleared Mar 3, 200679-day reviewClass I21 CFR 886.4570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Refractec, Inc. · HMR Marker, Ocular

Cleared on Mar 3, 2006 after a 79-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Mar 3, 2006
Review
79 days
Class
Class I
Product code
HMR
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K053475Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All HMR devices

HMR Marker, Ocular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HMR

FDA has decided no HMR device since 2007.

Median 510(k) review, days · HMR

Too few HMR 510(k)s in any year since 2007 to give a median.

Recalls per year · HMR

6in 2010

2010: 6
2007high 6 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HMR

8in 2025

2016: 12025: 8
2007high 8 (2025) · low 0 (2007)2025

MAUDE reports naming product code HMR, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—60
20110—00
20120—00
20130—00
20140—00
20150—00
20160—01
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—08
20260—0—

What is it indicated for?

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.

Indications for use as stated in the FDA 510(k) statement.

More from Refractec, Inc.

12 FDA decisions under this applicant name. See the company

Recent decisions in HMR

The HMR category page

  • K925606Optical Zone/Hexagonal/Astigmatism/Radial MarkersChiron Vision Corp. · 1994
  • K872747Laser Centering DeviceInnomed Corp. · 1987
  • K863663Ophthalmic Surgical Ocular MarkersMyocure, Inc. · 1986
  • K861535Optical Markers/Fixation Ring/Cannu & Irriga CannuCooperVision, Inc. · 1986

https://510kreport.com/device/K053475 · printed Nov 5, 2026

Cite this page

510(k) Report. “K053475: Optipoint Corneal Marker, Model VPT-Opt-450.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053475

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026