Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030967

FEI Number

1000640985

Entity Name

OERTLI INSTRUMENTE AG

City/State/Country

BERNECK Sankt Gallen, CH

Establishment Address

HAFNERWISENSTRASSE 4, BERNECK Sankt Gallen CH-9442, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OERTLI INSTRUMENTE AG (Owner Number: 8030967)

Owner / Operator Contact Address

HAFNERWISENSTRASSE 4, BERNECK, CH-SG CH-9442, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233398

PMA Number

N/A

All Registered Proprietary Names

Faros

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2014-11-13
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2014-11-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-11-13
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2024-11-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-11-27
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2024-11-27

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

OERTLI INSTRUMENTE AG

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K091915	Lenstec, Inc.	FLUID ISOLATION DEVICE	2009-10-27
K830812	Alphamedix, Inc.	ALPHAMEDIX I/A HAND-PIECE, 500-001	1983-06-08
K133115	Abbott Medical Optics, Inc.	COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK	2014-02-27
K121721	Abbott Medical Optics, Inc.	LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)	2012-10-15
K111697	Abbott Medical Optics, Inc.	AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM	2011-09-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-1670-2013	Abbott Medical Optics, Inc.	2	Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Z-0099-2024	Alcon Research, LLC	2	Constellation Vision System, REF: 8065751150
Z-0305-2026	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUMATOR,RFID,23G 8065751014 CONST AUTO GAS FILL PAK 8065751014 CONST AUTO GAS FILL PAK 8065751441 ENDOILLUMINATOR,RFID,25G 8065751577 CHANDELIER,25GA,W/RFID Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Z-1794-2020	Alcon Research LLC	2	Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
Z-2109-2025	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A

Similar Registrations

Registration Number	Establishment Name	Location
3013497605	Alcon Research, LLC	Sinking Spring, PA, US
3005012805	MIDWEST STERILIZATION CORP.	LAREDO, TX, US
2028159	Alcon Research, LLC	IRVINE, CA, US
1650907	Isomedix Operations Inc.	GRAND PRAIRIE, TX, US
3003365815	Bausch+Lomb Netherlands B.V. Amsterdam Logistics Centre	SCHIPOL RIJK Noord-Holland, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030967. Last updated year: 2026. Please use registration number 8030967 when referencing this establishment in official correspondence.