Cleared Traditional

VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY

K844715 · Optical Micro Systems, Inc. · Ophthalmic

Jan 1985

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K844715 is an FDA 510(k) clearance for the VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY, 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 January 22, 1985, 56 days after receiving the submission on November 27, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number	K844715 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 27, 1984
Decision Date	January 22, 1985
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—