Cleared Traditional

ASPIRATION REVERSAL CONTROL (ARC) MODULE

K870068 · Optical Micro Systems, Inc. · Ophthalmic
Feb 1987
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K870068 is an FDA 510(k) clearance for the ASPIRATION REVERSAL CONTROL (ARC) MODULE, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Optical Micro Systems, Inc. (Danvers, US). The FDA issued a Cleared decision on February 12, 1987, 35 days after receiving the submission on January 8, 1987. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K870068 FDA.gov
FDA Decision Cleared SESE
Date Received January 08, 1987
Decision Date February 12, 1987
Days to Decision 35 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HQE — Instrument, Vitreous Aspiration And Cutting, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4150

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