Oculus Optikgerate GmbH

WETZLAR Hesse, DE

OCULUS OPTIKGERATE GMBH appears in FDA device records in WETZLAR Hesse, DE. FDA records list 8 510(k) clearances between 2003-09-16 and 2026-03-13, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 7 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 8
PMA records: 0
Recall records: 7
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Oculus Optikgerate GmbH carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Oculus Optikgeraete GMBHenforcement report, recall

510(k) clearance history

FDA records hold 8 510(k) clearances for Oculus Optikgerate GmbH between 2003 and 2026. The busiest year on record is 2003, with 1. The most recent is 2026, with 1.

Clearances by year, as a table

510(k) clearance decisions for Oculus Optikgerate GmbH, by decision year
Year	Clearances
2003	1
2005	1
2008	1
2012	1
2016	1
2020	1
2021	1
2026	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K251848	Pentacam® Cornea OCT	MXK	Substantially Equivalent	2026-03-13
K202989	Myopia Master	MXK	Substantially Equivalent	2021-07-14
K201724	Pentacam AXL Wave	MXK	Substantially Equivalent	2020-10-21
K152311	Pentacam AXL	MXK	Substantially Equivalent	2016-01-20
K113066	CORVIS ST	HKX	Substantially Equivalent	2012-11-08
K073508	PARKONE	MXK	Substantially Equivalent	2008-09-11
K041841	PACHYCAM	MXK	Substantially Equivalent	2005-01-28
K030719	PENTACAM SCHEIMPFLUG CAMERA	MXK	Substantially Equivalent	2003-09-16

Registered establishments

FDA registered establishments for Oculus Optikgerate GmbH, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
9611269	3002807782	OCULUS OPTIKGERATE GMBH	MUNCHHOLZHAUSER STR. 29, WETZLAR Hesse D-35582 DE	2026	HIT HIW HJO HJQ HKS HKX HLG HLS HNI HOH and 13 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2484-2023	Oculus Myopia Master , Ref 68100, CE 0123	Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.	Class II	2023-08-08	Open, Classified
Z-2483-2023	Oculus Pentacam AXL , Ref 70100, CE 0123	Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.	Class II	2023-08-08	Open, Classified
Z-2482-2023	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.	Class II	2023-08-08	Open, Classified
Z-1674-2022	Pentacam 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 incision position when planning toric IOLs	Class II	2022-07-08	Open, Classified
Z-1673-2022	Pentacam AXL REF 70100, Pentacam 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 incision position when planning toric IOLs	Class II	2022-07-08	Open, Classified
Z-1672-2022	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	Class II	2022-07-08	Open, Classified
Z-0635-2018	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 anterior segment of the eye, which includes the cornea, pupil, anterior chamber, and lens of the eye, to evaluate corneal shape, analyze condition of the lens (opaque crystalline lens), analyze the anterior chamber angle, analyze anterior chamber depth, analyze the volume of the anterior chamber, analyze anterior or posterior cortical opacity, analyze the location of cataracts (nuclear, sub capsular and/or cortical), using cross slit imaging with densitometry, corneal thickness, axial length, and white-to-white distance. The Pentacam AXL also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.	The device software versions have an anomaly which may produce an erroneous marking for the quality specification value	Class II	2017-11-21	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain