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Ziemer Opthalmic Systems AG: FDA-registered device maker in Bruegg Bern, Switzerland, 6 510(k) clearances

Name: Ziemer Opthalmic Systems AG FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ziemer Opthalmic Systems AG is registered with the FDA (registration 3009298127) in Bruegg Bern, Switzerland. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 21, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009298127
Address: Erlenstrasse 31, Bruegg Bern, Switzerland, CH - 2555
Owner or operator: ZIEMER OPHTHALMIC SYSTEMS AG (9067737)
Roles: Manufacturer
First device listed: November 29, 2005
Registered through: 2026
Brand names listed: Artificial Anterior Chamber Base Set (AAC) for Femto LDV, Artificial Chamber Interface, FEMTO Crystal Line, FEMTO LDV Z2, FEMTO LDV Z4, FEMTO LDV Z6, FEMTO Z8 NEO, Femto LDV Z8 and more

Devices it lists

Device	Product code	Class	Role	Source
Device, Analysis, Anterior Segment	MXK	2	Manufacturer	accessdata.fda.gov
Keratome, Ac-Powered	HNO	1	Manufacturer	accessdata.fda.gov
Laser, Ophthalmic	HQF	2	Manufacturer	accessdata.fda.gov
Ophthalmic Femtosecond Laser	OOE	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov
Trephine, Manual, Ophthalmic	HRH	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
April 21, 2022	K213559	FEMTO LDV Z8 Femtosecond Surgical Laser	OOE	Substantially Equivalent	Sie Ag,Surgical Instrument Engineering	accessdata.fda.gov
July 25, 2019	K182659	Galilei G6 Lens Professional	MXK	Substantially Equivalent	Sis Ag, Surgical Instrument Systems	accessdata.fda.gov
October 23, 2015	K150323	FEMTO LDV Z8 Surgical Laser	OOE	Substantially Equivalent	Sie Ag,Surgical Instrument Engineering	accessdata.fda.gov
March 16, 2012	K112154	FEMTO LDV	HQF	Substantially Equivalent	Sie Ag,Surgical Instument Engineering	accessdata.fda.gov
March 10, 2006	K053511	DA VINCI FEMTOSECOND SURGICAL LASER	GEX	Substantially Equivalent	Sie Ltd Surgical Instrument Engineering	accessdata.fda.gov
September 28, 2005	K051940	CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA	MXK	Substantially Equivalent	Sis Ltd., Surgical Instrument Systems	accessdata.fda.gov

Compare with other makers

Updated April 21, 2022. 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.