System Sophi

FDA 510(k) K250501 · This AG

Substantially Equivalent

510(k) numberK250501

Submission

Device name
System Sophi
Applicant
This AG
Heerbrugg, CH
Received
February 20, 2025
Decision date
November 14, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HQC – Unit, Phacofragmentation
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4670
Specialty
Ophthalmic

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Questions and answers

When was System Sophi cleared by the FDA?

System Sophi (K250501) received a 510(k) decision of Substantially Equivalent on November 14, 2025, 267 days after the submission was received.

What is the product code of K250501?

The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.