Cleared Traditional

ML BLADE, MODEL ML7030

K010872 · Med-Logics, Inc. · Ophthalmic
Jun 2001
Decision
91d
Days
Class 1
Risk

About This 510(k) Submission

K010872 is an FDA 510(k) clearance for the ML BLADE, MODEL ML7030, 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 June 22, 2001, 91 days after receiving the submission on March 23, 2001. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number K010872 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2001
Decision Date June 22, 2001
Days to Decision 91 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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