Cleared Traditional

K030891 - SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK

K030891 is an FDA 510(k) clearance for SURGISTAR MICROKERATOME BLADE, manufactured by Surgistar, Inc.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K030891 · Surgistar, Inc. · Ophthalmic device
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Jun 2003
Decision
88d
Days
Class 1
Risk

K030891 is an FDA 510(k) clearance for the SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Surgistar, Inc. (Carlsbad, US). The FDA issued a Cleared decision on June 17, 2003 after a review of 88 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 Surgistar, Inc. devices

FDA 510(k) Submission Details - K030891

510(k) Number K030891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2003
Decision Date June 17, 2003
Days to Decision 88 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
22d faster than avg
Panel avg: 110d · This submission: 88d
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 50
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K030891.
DISPOSABLE N-PE MICKROKERATOME BLADES
K032297 · Oasis Medical, Inc. · Aug 2003
CENTURION SES EPIKERATOME
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K030401 · Oasis Medical, Inc. · Jun 2003
DISPOSABLE N-PE MICROKERATOME BLADES
K022205 · Oasis Medical, Inc. · Oct 2002
HANSATOME EXCELLUS MICROKERATOME
K021640 · Bausch & Lomb, Inc. · Jun 2002
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK
K011195 · Surgin Surgical Instrumentation, Inc. · Nov 2001