Cleared Traditional

PARKONE

K073508 · Oculus Optikgerate GmbH · Ophthalmic
Sep 2008
Decision
273d
Days
Class 2
Risk

About This 510(k) Submission

K073508 is an FDA 510(k) clearance for the PARKONE, a Device, Analysis, Anterior Segment (Class II — Special Controls, product code MXK), submitted by Oculus Optikgerate GmbH (Wetzlar, DE). The FDA issued a Cleared decision on September 11, 2008, 273 days after receiving the submission on December 13, 2007. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K073508 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2007
Decision Date September 11, 2008
Days to Decision 273 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MXK — Device, Analysis, Anterior Segment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1850