Cleared Abbreviated

KERAVISION VACUUM RING SYSTEM (K984540) - FDA 510(k) Clearance

Class I Ophthalmic device.

K984540 · Keravision, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
128d
Days
Class 1
Risk

K984540 is an FDA 510(k) clearance for the KERAVISION VACUUM RING SYSTEM. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Keravision, Inc. (Washington, US). The FDA issued a Cleared decision on April 28, 1999 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4370 - the FDA ophthalmic device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Keravision, Inc. devices

Submission Details

510(k) Number K984540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1998
Decision Date April 28, 1999
Days to Decision 128 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 110d · This submission: 128d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code HNO Keratome, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4370
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.