OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450— 510(k) K053475

Name: FDA 510(k) clearance K053475
Creator: U.S. Food and Drug Administration
Published: 2006-03-03

Substantially Equivalent

Refractec, Inc.

FDA 510(k) clearance K053475 for OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450, Substantially Equivalent on 2006-03-03. Applicant: Refractec, Inc.. Device class: 1.

Clearance details

Applicant: Refractec, Inc.
Product code: Code HMR
Device class: Class 1
Regulation: 21 CFR 886.4570
Advisory panel: Ophthalmic
Date received: 2005-12-14
Decision date: 2006-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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