FDA.report

SOPHI

Primary DI
07640179410090
Brand
SOPHI
Company
This AG
Model
1401-0100-A
Catalog number
1401-0100-A
Device description
SOPHI is a phacoemulsification device for lens removal designed for use in intraocular ophthalmic surgery in anterior chamber.
Published
2026-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HQCUnit, Phacofragmentation

Product Code Classifications

CodeDeviceSpecialtyClass
HQCUnit, PhacofragmentationOphthalmic2

Premarket Submissions

SubmissionSupplement
K250501000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K250501000System SophiThis AG2025-11-14HQC

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640179410090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640179410090076401794100907640179410090

GMDN Terms

TermDefinition
Phacoemulsification systemAn assembly of ophthalmic devices intended to deliver energy (e.g., ultrasonic, piezoelectric) through a dedicated handpiece tip, which is introduced through an incision made in the lens capsule, to perform phacoemulsification (a procedure for the liquefaction and removal of the opaque lens nucleus in cataract surgery). The system will typically consist of a mains electricity (AC-powered) generator providing the energy, an irrigation and suction system for the removal of the debris, handpieces and cables, the tips/needles/electrodes, and a foot control.

Sterilization Methods

Method

Contacts

PhoneEmail
+41715440870supportsophi@rayner.com

Regulatory Flags

DUNS number
480032801
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
07640179410755Cassette Peristaltic Sophi 1401-52001401-52002026-02-11
07640179410779Cassette Peristaltic & Venturi Sophi1401-52101401-52102026-02-11
07640179410793Cassette Peristaltic Sophi ECO1401-52031401-52032026-02-11
07640179410007SOPHI1401-0100-ACW1401-0100-ACW2026-02-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07630055210449Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07630055210456Phaco Set Sophi - 21G/30°This AGHQC2026-02-11
07630055210463Phaco Set Sophi - 23G/30°This AGHQC2026-02-11
07630055210869Phaco Set Sophi - 20G/CurvedThis AGHQC2026-02-11
07630055210876Phaco Set Sophi - 21G/CurvedThis AGHQC2026-02-11
07630055210883Phaco Set Sophi - 23G/CurvedThis AGHQC2026-02-11
07630055242884HighVac Phaco Set Sophi - 21G/30° 0.45This AGHQC2026-02-11
07630055243294Dynamic Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07640179410236SOPHI AThis AGHQC2026-02-11
07640179410755Cassette Peristaltic Sophi This AGHQC2026-02-11
07640179410779Cassette Peristaltic & Venturi SophiThis AGHQC2026-02-11
07640179410793Cassette Peristaltic Sophi ECOThis AGHQC2026-02-11
07640179410007SOPHIThis AGHQC2026-02-10
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07630003910339Oertli®Oertli-Instrumente AGHQC2025-12-19
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07630003920178Oertli®Oertli-Instrumente AGHQC2025-09-19
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00757770684571Bausch + LombBausch & Lomb IncorporatedHQC2025-07-18
10380650003208UNITYAlcon Laboratories, Inc.HQC2025-04-07
10380650003215UNITYAlcon Laboratories, Inc.HQC2025-04-07
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10380650003239UNITYAlcon Laboratories, Inc.HQC2025-04-07
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10380650003369UNITYAlcon Laboratories, Inc.HQC2025-04-07
10380650003376UNITYAlcon Laboratories, Inc.HQC2025-04-07
10380650003383UNITYAlcon Laboratories, Inc.HQC2025-04-07
10380650003437UNITYAlcon Laboratories, Inc.HQC2025-04-07
00380650003447UNITYAlcon Laboratories, Inc.HQC2025-04-07
10380650003451UNITYAlcon Laboratories, Inc.HQC2025-04-07