Cleared Traditional

VISIJET HYDROKERATOME, MODEL 50 (K991124) - FDA 510(k) Clearance

Class I Ophthalmic device.

K991124 · Visijet, Inc. · Ophthalmic device
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Oct 2000
Decision
567d
Days
Class 1
Risk

K991124 is an FDA 510(k) clearance for the VISIJET HYDROKERATOME, MODEL 50. Classified as Keratome, Water Jet (product code MYD), Class I - General Controls.

Submitted by Visijet, Inc. (Irvine, US). The FDA issued a Cleared decision on October 20, 2000 after a review of 567 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4370 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Visijet, Inc. devices

Submission Details

510(k) Number K991124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1999
Decision Date October 20, 2000
Days to Decision 567 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
457d slower than avg
Panel avg: 110d · This submission: 567d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MYD Keratome, Water Jet
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.