Cleared Traditional

DISPOSABLE MICROKERATOME BLADES-PE

K001176 · Oasis Medical, Inc. · Ophthalmic
Sep 2000
Decision
163d
Days
Class 1
Risk

About This 510(k) Submission

K001176 is an FDA 510(k) clearance for the DISPOSABLE MICROKERATOME BLADES-PE, a Keratome, Ac-powered (Class I — General Controls, product code HNO), submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on September 21, 2000, 163 days after receiving the submission on April 11, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number K001176 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2000
Decision Date September 21, 2000
Days to Decision 163 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

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

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