Cleared Traditional

ULTRASHAPER KERATOME (K990227) - FDA 510(k) Clearance

Class I Ophthalmic device.

K990227 · Lasersight Technologies, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
371d
Days
Class 1
Risk

K990227 is an FDA 510(k) clearance for the ULTRASHAPER KERATOME. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Lasersight Technologies, Inc. (Winter Park, US). The FDA issued a Cleared decision on January 31, 2000 after a review of 371 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Lasersight Technologies, Inc. devices

Submission Details

510(k) Number K990227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1999
Decision Date January 31, 2000
Days to Decision 371 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
261d slower than avg
Panel avg: 110d · This submission: 371d
Pathway characteristics
Predicate-based equivalence.

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.