Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009298127

FEI Number

3009298127

Entity Name

Ziemer Opthalmic Systems AG

City/State/Country

Bruegg Bern, CH

Establishment Address

Erlenstrasse 31, Bruegg Bern CH - 2555, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ZIEMER OPHTHALMIC SYSTEMS AG (Owner Number: 9067737)

Owner / Operator Contact Address

Allmendstrasse 11, --, PORT, CH-NOTA CH - 2562, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K051940

PMA Number

N/A

All Registered Proprietary Names

Procedure Packs FEMTO Crystal Line Procedure Packs LCS Intershield for LCS FEMTO LDV Z4 FEMTO LDV Z2 FEMTO LDV Z6 Procedure Packs Procedure Packs Corneal Surgery Procedure Packs LASIK Procedure Packs Advanced Corneal Surgery Procedure Packs for Corneal Surgery FEMTO Z8 NEO Procedure Packs for Cataract Surgery Procedure Packs for Corneal Surgery Liquid Galilei G6 Artificial Anterior Chamber Base Set (AAC) for Femto LDV Artificial Chamber Interface Galilei G4

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-10-23
HNO	Keratome, Ac-Powered	Ophthalmic	Class 1	886.4370	2007-10-23
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2012-10-23
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2022-06-09
MXK	Device, Analysis, Anterior Segment	Ophthalmic	Class 2	886.1850	2019-09-18
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2015-10-11
MXK	Device, Analysis, Anterior Segment	Ophthalmic	Class 2	886.1850	2005-11-29

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: REGULATORY INSIGHT, INC. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

ZIEMER OPHTHALMIC SYSTEMS AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004858034	ZIEMER OPHTHALMIC SYSTEMS AG	PORT Bern, CH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15
K142225	CAO Group, Inc.	Pilot Elite Diode Laser	2014-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-1515-2015	Abbott Medical Optics, Inc.	2	OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009298127. Last updated year: 2026. Please use registration number 3009298127 when referencing this establishment in official correspondence.