Cleared Traditional

ANISEIKONIA INSPECTOR (K013110) - FDA 510(k) Clearance

Class I Ophthalmic device.

K013110 · Optical Diagnostics, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
161d
Days
Class 1
Risk

K013110 is an FDA 510(k) clearance for the ANISEIKONIA INSPECTOR. Classified as Haploscope (product code HJT), Class I - General Controls.

Submitted by Optical Diagnostics, Inc. (Issaquah, US). The FDA issued a Cleared decision on December 19, 2001 after a review of 161 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1340 - 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 Optical Diagnostics, Inc. devices

Submission Details

510(k) Number K013110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2001
Decision Date December 19, 2001
Days to Decision 161 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 110d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HJT Haploscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1340
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.