FDA.reportPublic FDA data

Phaco Set Sophi - 23G/30°

Primary DI
07630055210333
Brand
Phaco Set Sophi - 23G/30°
Company
This AG
Model
1401-2023
Catalog number
1401-2023
Published
2026-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQCUnit, Phacofragmentation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQCUnit, PhacofragmentationOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250501000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250501000System SophiThis AG2025-11-14HQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630055210333PrimaryGS10
07630055210463Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630055210333076300552103337630055210333
07630055210463076300552104637630055210463

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-useA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+41715440870supportsophi@rayner.com

Regulatory Flags#

DUNS number
480032801
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630055210319Phaco Set Sophi - 20G/30°1401-20201401-20202026-02-11
07630055210326Phaco Set Sophi - 21G/30°1401-20211401-20212026-02-11
07630055210807Phaco Set Sophi - 20G/Curved1401-27201401-27202026-02-11
07630055210814Phaco Set Sophi - 21G/Curved1401-27211401-27212026-02-11
07630055210821Phaco Set Sophi - 23G/Curved1401-27231401-27232026-02-11
07630055252883HighVac Phaco Set Sophi - 21G/30° 0.451401-28211401-28212026-02-11
07630055253293Dynamic Phaco Set Sophi - 20G/30°1401-30201401-30202026-02-11
07640179410762Cassette Peristaltic Sophi 1401-52001401-52002026-02-11
07640179410786Cassette Peristaltic & Venturi Sophi1401-52101401-52102026-02-11
07640179410809Cassette Peristaltic Sophi ECO1401-52031401-52032026-02-11
04251954900014Phaco Handpiece Sophi ECO1401-20101401-20102026-02-11
07630055210449Phaco Set Sophi - 20G/30°1401-20201401-20202026-02-11
07630055210456Phaco Set Sophi - 21G/30°1401-20211401-20212026-02-11
07630055210463Phaco Set Sophi - 23G/30°1401-20231401-20232026-02-11
07630055210869Phaco Set Sophi - 20G/Curved1401-27201401-27202026-02-11
07630055210876Phaco Set Sophi - 21G/Curved1401-27211401-27212026-02-11
07630055210883Phaco Set Sophi - 23G/Curved1401-27231401-27232026-02-11
07630055242884HighVac Phaco Set Sophi - 21G/30° 0.451401-28211401-28212026-02-11
07630055243294Dynamic Phaco Set Sophi - 20G/30°1401-30201401-30202026-02-11
07640179410236SOPHI A1801-01001801-01002026-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380657530274LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530281LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530298LEGION, INTREPIDAlcon Laboratories, Inc.HQC2026-07-22
00380657530373LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530502LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530564LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530755LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657531639LEGION, KELMANAlcon Laboratories, Inc.HQC2026-07-22
00380657531646LEGION, KELMANAlcon Laboratories, Inc.HQC2026-07-22
00380657531653LEGION, INTREPID, KELMANAlcon Laboratories, Inc.HQC2026-07-22
00380657531660LEGION, INTREPID, KELMANAlcon Laboratories, Inc.HQC2026-07-22
07630055210319Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07630055210326Phaco Set Sophi - 21G/30°This AGHQC2026-02-11
07630055210807Phaco Set Sophi - 20G/CurvedThis AGHQC2026-02-11
07630055210814Phaco Set Sophi - 21G/CurvedThis AGHQC2026-02-11
07630055210821Phaco Set Sophi - 23G/CurvedThis AGHQC2026-02-11
07630055252883HighVac Phaco Set Sophi - 21G/30° 0.45This AGHQC2026-02-11
07630055253293Dynamic Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07640179410762Cassette Peristaltic Sophi This AGHQC2026-02-11
07640179410786Cassette Peristaltic & Venturi SophiThis AGHQC2026-02-11
07640179410809Cassette Peristaltic Sophi ECOThis AGHQC2026-02-11
08717872035390Endoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.4D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872035413TotalView Endoillumination Probe, including illuminated scleral depressor.(27 gaD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872035437Shielded TotalView Endoillumination Probe, including illuminated scleral depressD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
0871787203553627G Ultra Short Shielded TotalView Endoillumination Probe, Including scleral depD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872035604Shielded TotalView Endoillumination Probe, including illuminated scleral depressD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872036526EVA Cartridge with 0.5 L Collection BagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872036588Disposable EVA Air Fluid Dual Tubing D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872036595Disposable EVA DrapesD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872036601Disposable EVA VGPC Input SetD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31