Pentacam AXL

FDA 510(k) K152311 · Oculus Optikgerate GmbH

Substantially Equivalent

510(k) numberK152311

Submission

Device name
Pentacam AXL
Applicant
Oculus Optikgerate GmbH
Wetzla, DE
Received
August 14, 2015
Decision date
January 20, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MXK – Device, Analysis, Anterior Segment
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1850
Specialty
Ophthalmic

Other 510(k)s with product code MXK

510(k)DeviceApplicantDecision
K251848Pentacam® Cornea OCTMXK · Traditional Oculus Optikgeräte GmbH03/13/2026SE
K252348Tomey Optical Biometer OA-2000 (OA-2000)MXK · Traditional Tomey Corporation12/18/2025SE
K223700Boss™MXK · Traditional Intelon Optics, Inc.08/16/2024SE
K222933MyahMXK · Traditional Visia Imaging S.R.L.06/29/2023SE
K211868MyahMXK · Traditional Visia Imaging S.R.L.03/01/2022SE
K202989Myopia MasterMXK · Traditional Oculus Optikgeräte GmbH07/14/2021SE
K201724Pentacam AXL WaveMXK · Traditional Oculus Optikgerate GmbH10/21/2020SE
K182659Galilei G6 Lens ProfessionalMXK · Traditional Sis Ag, Surgical Instrument Systems07/25/2019SE
K191051ArgosMXK · Traditional Santec Corporation05/16/2019SE
K150754ArgosMXK · Traditional Santec Corporation10/02/2015SE

More from Santec Corporation

510(k)DeviceDecision
K201724Pentacam AXL WaveMXK · Traditional 10/21/2020SE
K113066Corvis STHKX · Traditional 11/08/2012SE
K073508ParkoneMXK · Traditional 09/11/2008SE
K041841PachycamMXK · Traditional 01/28/2005SE
K030719Pentacam Scheimpflug CameraMXK · Traditional 09/16/2003SE

Questions and answers

When was Pentacam AXL cleared by the FDA?

Pentacam AXL (K152311) received a 510(k) decision of Substantially Equivalent on January 20, 2016, 159 days after the submission was received.

What is the product code of K152311?

The FDA product code is MXK – Device, Analysis, Anterior Segment, a Class II (moderate risk) device regulated under 21 CFR 886.1850.