SOPHI

Basic Information

• Brand Name: SOPHI
• Primary DI: 07640179410007
• Version / Model: 1401-0100-ACW
• Catalog Number: 1401-0100-ACW
• Company Name: This AG
• Labeler DUNS: 480032801
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-10
• Public Version: 1
• Public Version Date: 2026-02-18
• Public Version Status: New
• Public Device Record Key: 5b54752b-851b-44f0-b346-55cb16ee6253

Device Description

SOPHI is a phacoemulsification device for lens removal designed for use in intraocular ophthalmic surgery in anterior chamber.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQC	Unit, Phacofragmentation	Ophthalmic	886.4670	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45071	Phacoemulsification system	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640179410007	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K250501	000