Cleared Traditional

K002515 - MEDLOGICS ML 4000, MODEL 4000

K002515 is an FDA 510(k) clearance for MEDLOGICS ML 4000, manufactured by Med-Logics, Inc.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K002515 · Med-Logics, Inc. · Ophthalmic device
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Feb 2001
Decision
191d
Days
Class 1
Risk

K002515 is an FDA 510(k) clearance for the MEDLOGICS ML 4000, MODEL 4000. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Med-Logics, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on February 22, 2001 after a review of 191 days - an extended review 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: 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 Med-Logics, Inc. devices

FDA 510(k) Submission Details - K002515

510(k) Number K002515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2000
Decision Date February 22, 2001
Days to Decision 191 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
81d slower than avg
Panel avg: 110d · This submission: 191d
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 42
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K002515.
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK
K011195 · Surgin Surgical Instrumentation, Inc. · Nov 2001
HANSATOME MICROKERATOME
K010260 · Bausch & Lomb, Inc. · Apr 2001
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