Cleared Abbreviated

K984540 - KERAVISION VACUUM RING SYSTEM

K984540 is an FDA 510(k) clearance for KERAVISION VACUUM RING SYSTEM, manufactured by Keravision, Inc.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Abbreviated 510(k) pathway after a 128-day FDA review.

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

FDA 510(k) Submission Details - K984540

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 110d · This submission: 128d
Pathway characteristics
Standards-based clearance path.

HNO Device Classification - Class 1, General Controls

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.

Regulatory Peers - HNO Keratome, Ac-powered

All 42
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K984540.
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
K994015 · Surgin Surgical Instrumentation, Inc. · Mar 2000
ULTRASHAPER KERATOME
K990227 · Lasersight Technologies, Inc. · Jan 2000
MICROKERATOME, MODEL MK-2000
K990900 · Nidek, Inc. · Sep 1999
SUMMIT KRUMEICH-BARRAQUER MICROKERATOME
K980675 · Summit Technology, Inc. · Dec 1998
MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI)
K981554 · Micra Instruments , Ltd. · Dec 1998
BARRON MICROKERATOME SYSTEM, MODEL B2000
K983317 · Barron Precision Instruments, LLC · Dec 1998