Cleared Traditional

KERATOME SYSTEM, MODEL K3000 (K984537) - FDA 510(k) Clearance

Class I Ophthalmic device.

K984537 · Insight Technologies Instruments, LLC · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
144d
Days
Class 1
Risk

K984537 is an FDA 510(k) clearance for the KERATOME SYSTEM, MODEL K3000. Classified as Keratome, Battery-powered (product code HMY), Class I - General Controls.

Submitted by Insight Technologies Instruments, LLC (Milford, US). The FDA issued a Cleared decision on May 14, 1999 after a review of 144 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 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 Insight Technologies Instruments, LLC devices

Submission Details

510(k) Number K984537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1998
Decision Date May 14, 1999
Days to Decision 144 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
34d slower than avg
Panel avg: 110d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HMY Keratome, Battery-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.