Cleared Traditional

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

Class I Ophthalmic device.

K053475 · Refractec, Inc. · Ophthalmic device
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Mar 2006
Decision
79d
Days
Class 1
Risk

K053475 is an FDA 510(k) clearance for the OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450. Classified as Marker, Ocular (product code HMR), Class I - General Controls.

Submitted by Refractec, Inc. (Irvine, US). The FDA issued a Cleared decision on March 3, 2006 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4570 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Refractec, Inc. devices

Submission Details

510(k) Number K053475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2005
Decision Date March 03, 2006
Days to Decision 79 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 110d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HMR Marker, Ocular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4570
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.