Cleared Traditional

MICROVISION SCLERAL BUCKLING COMPONENTS

K023481 · Microvision, Inc. · Ophthalmic
Jan 2003
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K023481 is an FDA 510(k) clearance for the MICROVISION SCLERAL BUCKLING COMPONENTS, a Implant, Orbital, Extra-ocular (Class II — Special Controls, product code HQX), submitted by Microvision, Inc. (North Attleboro, US). The FDA issued a Cleared decision on January 8, 2003, 83 days after receiving the submission on October 17, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3340.

Submission Details

510(k) Number K023481 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 2002
Decision Date January 08, 2003
Days to Decision 83 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQX — Implant, Orbital, Extra-ocular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.3340

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