Cleared Traditional

Pentacam AXL

K152311 · Oculus Optikgerate GmbH · Ophthalmic
Jan 2016
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K152311 is an FDA 510(k) clearance for the Pentacam AXL, a Device, Analysis, Anterior Segment (Class II — Special Controls, product code MXK), submitted by Oculus Optikgerate GmbH (Wetzla, DE). The FDA issued a Cleared decision on January 20, 2016, 159 days after receiving the submission on August 14, 2015. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K152311 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2015
Decision Date January 20, 2016
Days to Decision 159 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