Cleared Traditional

CONSTELLATION VISION SYSTEM

K101285 · Alcon Manufacturing, Ltd. · Ophthalmic
Nov 2010
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K101285 is an FDA 510(k) clearance for the CONSTELLATION VISION SYSTEM, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Alcon Manufacturing, Ltd. (Irvine, US). The FDA issued a Cleared decision on November 12, 2010, 189 days after receiving the submission on May 7, 2010. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K101285 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2010
Decision Date November 12, 2010
Days to Decision 189 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQC — Unit, Phacofragmentation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4670

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