Cleared Traditional

MEDLOGICS ML 4000, MODEL 4000

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

About This 510(k) Submission

K002515 is an FDA 510(k) clearance for the MEDLOGICS ML 4000, MODEL 4000, a Keratome, Ac-powered (Class I — General Controls, product code HNO), submitted by Med-Logics, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on February 22, 2001, 191 days after receiving the submission on August 15, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number K002515 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code HNO — Keratome, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4370

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