Cleared Traditional

K852424 - ACUFEX COMPARATIVE SURGICAL KERATOMETER (FDA 510(k) Clearance)

Class I Ophthalmic device.

K852424 · Acufex Microsurgical, Inc. · Ophthalmic device
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Sep 1985
Decision
96d
Days
Class 1
Risk

K852424 is an FDA 510(k) clearance for the ACUFEX COMPARATIVE SURGICAL KERATOMETER. Classified as Instrument, Measuring, Corneal Radius (product code HJB), Class I - General Controls.

Submitted by Acufex Microsurgical, Inc. (Norwood, US). The FDA issued a Cleared decision on September 11, 1985 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1450 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Acufex Microsurgical, Inc. devices

Submission Details

510(k) Number K852424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1985
Decision Date September 11, 1985
Days to Decision 96 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 110d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HJB Instrument, Measuring, Corneal Radius
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1450
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.