Device, Analysis, Anterior Segment

FDA product code MXK · Class II (moderate risk) · 21 CFR 886.1850 · Ophthalmic

23510(k) clearances
0PMA approvals
7recalls

Manufacturers

510(k) clearances

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
K152311Pentacam AXLMXK · Traditional Oculus Optikgerate GmbH01/20/2016SE
K150754ArgosMXK · Traditional Santec Corporation10/02/2015SE
K073508ParkoneMXK · Traditional Oculus Optikgerate GmbH09/11/2008SE
K071183Allegro OculyzerMXK · Traditional Wavelight AG07/20/2007SE
K052935Heidelberg Engineering Slitlamp-Oct (Sl-Oct)MXK · Traditional Heidelberg Engineering01/13/2006SE
K051940CM 3910 Rotating Double Scheimpflug CameraMXK · Traditional Sis Ltd., Surgical Instrument Systems09/28/2005SE
K041841PachycamMXK · Traditional Oculus Optikgerate GmbH01/28/2005SE
K042742Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM)MXK · Traditional Heidelberg Engineering10/13/2004SE
K031788PathfinderMXK · Traditional Massie Research Laboratories, Inc.09/02/2004SE
K040913Ngdi (Next Generation Diagnostic Instrument)MXK · Traditional Bausch & Lomb07/23/2004SE
K030393Optical Low Coherence Reflectometry (Olcr) PachymeterMXK · Traditional Haag-Streit Holding AG09/25/2003SE
K030719Pentacam Scheimpflug CameraMXK · Traditional Oculus Optikgerate GmbH09/16/2003SE
K991284Anterior Eye-Segment Analysis SystemMXK · Traditional Nidek, Inc.08/06/1999SE
K984443OrbscanMXK · Traditional Technolas Perfect Vision GmbH03/05/1999SE

Recalls

RecallProductFirmInitiated
Z-2484-2023 Class IIOculus Myopia Master , Ref 68100, CE 0123Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect… Oculus Optikgeraete GMBH08/08/2023Open, Classified
Z-2483-2023 Class IIOculus Pentacam AXL , Ref 70100, CE 0123Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect… Oculus Optikgeraete GMBH08/08/2023Open, Classified
Z-2482-2023 Class IIOculus Pentacam AXL Wave, Ref 70020, CE 0123Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect… Oculus Optikgeraete GMBH08/08/2023Open, Classified
Z-1674-2022 Class IIPentacam HR REF 70900. Used to image the anterior segment of the eye.Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and… Oculus Optikgeraete GMBH07/08/2022Open, Classified
Z-1673-2022 Class IIPentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the…Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and… Oculus Optikgeraete GMBH07/08/2022Open, Classified
Z-1672-2022 Class IIPentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and… Oculus Optikgeraete GMBH07/08/2022Open, Classified
Z-0635-2018 Class IIOCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and…The device software versions have an anomaly which may produce an erroneous marking for the quality… Oculus Optikgeraete GMBH11/21/2017Terminated