Cleared Traditional

K001144 - ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS

K001144 is an FDA 510(k) clearance for ULTRAEDGE KERATOME BLADE, manufactured by Lasersight Technologies, Inc.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K001144 · Lasersight Technologies, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
25d
Days
Class 1
Risk

K001144 is an FDA 510(k) clearance for the ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS. 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 May 5, 2000 after a review of 25 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lasersight Technologies, Inc. devices

FDA 510(k) Submission Details - K001144

510(k) Number K001144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2000
Decision Date May 05, 2000
Days to Decision 25 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
85d faster than avg
Panel avg: 110d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

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 43
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K001144.
DISPOSABLE CB-PE MICROKERATOME BLADES
K003820 · Oasis Medical, Inc. · Mar 2001
PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES
K002849 · Surgical Specialties Corp · Oct 2000
DISPOSABLE MICROKERATOME BLADES-PE
K001176 · Oasis Medical, Inc. · Sep 2000
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