Cleared Traditional

ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER) (K912740) - FDA 510(k) Clearance

Class I Ophthalmic device.

K912740 · Visionary Systems, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
192d
Days
Class 1
Risk

K912740 is an FDA 510(k) clearance for the ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER). Classified as Keratoscope, Ac-powered (product code HLQ), Class I - General Controls.

Submitted by Visionary Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on December 30, 1991 after a review of 192 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1350 - 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 Visionary Systems, Inc. devices

Submission Details

510(k) Number K912740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1991
Decision Date December 30, 1991
Days to Decision 192 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
82d slower than avg
Panel avg: 110d · This submission: 192d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HLQ Keratoscope, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1350
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.