Cleared Traditional

Pentacam AXL Wave

K201724 · Oculus Optikgerate GmbH · Ophthalmic

Oct 2020

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K201724 is an FDA 510(k) clearance for the Pentacam AXL Wave, 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 October 21, 2020, 120 days after receiving the submission on June 23, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number	K201724 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 23, 2020
Decision Date	October 21, 2020
Days to Decision	120 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF