Cleared Traditional

AA-1 SYSTEM (K012530) - FDA 510(k) Clearance

Class I Ophthalmic device.

K012530 · Neurovision, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
25d
Days
Class 1
Risk

K012530 is an FDA 510(k) clearance for the AA-1 SYSTEM. Classified as Haploscope (product code HJT), Class I - General Controls.

Submitted by Neurovision, Inc. (Rockville, US). The FDA issued a Cleared decision on August 31, 2001 after a review of 25 days - a notably fast clearance 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: 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 Neurovision, Inc. devices

Submission Details

510(k) Number K012530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2001
Decision Date August 31, 2001
Days to Decision 25 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
85d faster than avg
Panel avg: 110d · This submission: 25d
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.