Cleared Traditional

MAIA, MODEL 1

K092187 · Centervue S.P.A. · Ophthalmic
May 2010
Decision
310d
Days
Class 1
Risk

About This 510(k) Submission

K092187 is an FDA 510(k) clearance for the MAIA, MODEL 1, a Perimeter, Automatic, Ac-powered (Class I — General Controls, product code HPT), submitted by Centervue S.P.A. (Padova, IT). The FDA issued a Cleared decision on May 27, 2010, 310 days after receiving the submission on July 21, 2009. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1605.

Submission Details

510(k) Number K092187 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 2009
Decision Date May 27, 2010
Days to Decision 310 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HPT — Perimeter, Automatic, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1605

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