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510(k) K201724

Device
Pentacam AXL Wave
Applicant
OCULUS Optikgerate GmbH
510(k) number
K201724
Product code
MXK  
Decision
Substantially Equivalent (SESE)
Decision date
2020-10-21
Date received
2020-06-23
Regulation
886.1850
Classification name
Device, Analysis, Anterior Segment
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Eckhard Loh
Address
Munchholzhauser Strabe 29 Wetzlar DE 35582 35582

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MXK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH2026-03-13
K252348Tomey Optical Biometer OA-2000 (OA-2000)Tomey Corporation2025-12-18
K223700BOSS™Intelon Optics, Inc.2024-08-16
K222933MYAHVisia Imaging S.R.L.2023-06-29
K211868MYAHVisia Imaging S.R.L.2022-03-01
K202989Myopia MasterOculus Optikgeräte GmbH2021-07-14
K182659Galilei G6 Lens ProfessionalSis Ag, Surgical Instrument Systems2019-07-25
K191051ARGOSSantec Corporation2019-05-16
K152311Pentacam AXLOculus Optikgerate GmbH2016-01-20
K150754ARGOSSantec Corporation2015-10-02
K073508PARKONEOculus Optikgerate GmbH2008-09-11
K071183ALLEGRO OCULYZERWavelight AG2007-07-20
K052935HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)Heidelberg Engineering2006-01-13
K051940CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERASis Ltd., Surgical Instrument Systems2005-09-28
K041841PACHYCAMOculus Optikgerate GmbH2005-01-28

Legacy Summary#

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FDA Review#

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