ZIEMER OPHTHALMIC SYSTEMS AG

FDA Device Registration & Listing · PORT Bern, CH · Registration 3004858034

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004858034
FEI Number
3004858034
Entity Name
ZIEMER OPHTHALMIC SYSTEMS AG
City/State/Country
PORT Bern, CH
Establishment Address
ALLMENDSTRASSE 11, PORT Bern CH - 2562, 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
N
Expiration Date (Year)
2026
510(k) Number
K150323
PMA Number
N/A

All Registered Proprietary Names

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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MXK Device, Analysis, Anterior Segment Ophthalmic Class 2 886.1850 2005-11-29
OOE Ophthalmic Femtosecond Laser Ophthalmic Class 2 886.4390 2022-06-09
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
HRH Trephine, Manual, Ophthalmic Ophthalmic Class 1 886.4350 2015-10-11
MXK Device, Analysis, Anterior Segment Ophthalmic Class 2 886.1850 2019-09-18
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2012-10-23
OOE Ophthalmic Femtosecond Laser Ophthalmic Class 2 886.4390 2017-03-17

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
3009298127 Ziemer Opthalmic Systems AG Bruegg Bern, CH

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K170322 Abbott Medical Optics, Inc. Catalys Precision Laser System 2017-05-19
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004858034. Last updated year: 2026. Please use registration number 3004858034 when referencing this establishment in official correspondence.
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