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Oculus Optikgerate GMBH: FDA-registered device maker in WETZLAR Hesse, Germany, 6 510(k) clearances

Name: Oculus Optikgerate GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Oculus Optikgerate GMBH is registered with the FDA (registration 9611269) in WETZLAR Hesse, Germany. It lists 23 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 13, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9611269
FEI number: 3002807782
Address: Munchholzhauser STR. 29, WETZLAR Hesse, Germany, D-35582
Owner or operator: OCULUS OPTIKGERATE GMBH (8010318)
Roles: Manufacturer
First device listed: April 20, 1978
Registered through: 2026
Brand names listed: Anomaloscope, BINOCULAR INDIRECT OPHTHALMO MICROS, BIOM 5, BIOM 6, BIOM 6 Optic Set, BIOM Optic Set, BIOM Versa Optic Set, BIOM ready and more

Devices it lists

Device	Product code	Class	Role	Source
Anomaloscope	HIW	1	Manufacturer	accessdata.fda.gov
Biomicroscope, Slit-Lamp, Ac-Powered	HJO	2	Manufacturer	accessdata.fda.gov
Camera, Surgical And Accessories	KQM	1	Manufacturer	accessdata.fda.gov
Chart, Visual Acuity	HOX	1	Manufacturer	accessdata.fda.gov
Device, Analysis, Anterior Segment	MXK	2	Manufacturer	accessdata.fda.gov
Exophthalmometer	HLS	1	Manufacturer	accessdata.fda.gov
Frame, Trial, Ophthalmic	HPA	1	Manufacturer	accessdata.fda.gov
Lens, Bagolini	HPD	1	Manufacturer	accessdata.fda.gov
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	HRM	1	Manufacturer	accessdata.fda.gov
Perimeter, Ac-Powered	HOO	1	Manufacturer	accessdata.fda.gov
Perimeter, Automatic, Ac-Powered	HPT	1	Manufacturer	accessdata.fda.gov
Prism, Gonioscopic	HKS	1	Manufacturer	accessdata.fda.gov
Pupillometer, Ac-Powered	HLG	1	Manufacturer	accessdata.fda.gov
Retractor, Ophthalmic	HNI	1	Manufacturer	accessdata.fda.gov
Set, Lens, Trial, Ophthalmic	HPC	1	Manufacturer	accessdata.fda.gov
Spectacle, Magnifying	HOI	1	Manufacturer	accessdata.fda.gov
Spectacle, Operating (Loupe), Ophthalmic	HOH	1	Manufacturer	accessdata.fda.gov
Stereoscope, Ac-Powered	HJQ	1	Manufacturer	accessdata.fda.gov
Table, Instrument, Powered, Ophthalmic	HRJ	1	Manufacturer	accessdata.fda.gov
Tester, Color Vision	HIT	1	Manufacturer	accessdata.fda.gov
Tomography, Optical Coherence	OBO	2	Manufacturer	accessdata.fda.gov
Tonometer, Ac-Powered	HKX	2	Manufacturer	accessdata.fda.gov
Topographer, Corneal, Ac-Powered	MMQ	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 13, 2026	K251848	Pentacam® Cornea OCT	MXK	Substantially Equivalent	Oculus Optikgeräte GmbH	accessdata.fda.gov
July 14, 2021	K202989	Myopia Master	MXK	Substantially Equivalent	Oculus Optikgeräte GmbH	accessdata.fda.gov
October 21, 2020	K201724	Pentacam AXL Wave	MXK	Substantially Equivalent	Oculus Optikgerate GmbH	accessdata.fda.gov
January 20, 2016	K152311	Pentacam AXL	MXK	Substantially Equivalent	Oculus Optikgerate GmbH	accessdata.fda.gov
November 8, 2012	K113066	CORVIS ST	HKX	Substantially Equivalent	Oculus Optikgerate GmbH	accessdata.fda.gov
September 16, 2003	K030719	PENTACAM SCHEIMPFLUG CAMERA	MXK	Substantially Equivalent	Oculus Optikgerate GmbH	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 8, 2023	92847	Class II	Ongoing	Oculus Pentacam AXL Wave, Ref 70020, CE 0123	Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.	accessdata.fda.gov
July 8, 2022	90661	Class II	Ongoing	Pentacam 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 incision position when planning toric IOLs	accessdata.fda.gov
November 21, 2017	78606	Class II	Terminated	OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to take photos of the anter	The device software versions have an anomaly which may produce an erroneous marking for the quality specification value	accessdata.fda.gov

Compare with other makers

Updated March 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.