Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042928348

FEI Number

3042928348

Entity Name

THIS AG

City/State/Country

Heerbrugg Sankt Gallen, CH

Establishment Address

Widnauerstrasse 1, Heerbrugg Sankt Gallen 9435, CH

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

This AG (Owner Number: 10094659)

Owner / Operator Contact Address

Widnauerstrasse 1, Heerbrugg, CH-SG 9435, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250501

PMA Number

N/A

All Registered Proprietary Names

Sophi

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2025-12-15
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2025-12-15

Official Correspondent

Silke Wallaschek

US Agent Details

Scott Corning Business: Rayner Surgical Inc Email: scottcorning@rayner.com Phone: (844) 7296371

Related Public Records

Same Entity

This 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-0306-2026	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' 8065000393 UNITY HP VISCOUS FLUID CONTROL VFC PACK 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-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.

Similar Registrations

Registration Number	Establishment Name	Location
1920664	Bausch & Lomb Incorporated	Saint Louis, MO, US
1928237	MIDWEST STERILIZATION CORP.	JACKSON, MO, US
3010208880	Alcon Research, LLC	Lake Forest, CA, US
1644019	Alcon Research, LLC	Houston, TX, US
3015456951	Alcon Laboratories Belgium	Puurs-Sint-Amands Antwerpen, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042928348. Last updated year: 2026. Please use registration number 3042928348 when referencing this establishment in official correspondence.