Cleared Traditional

System Sophi

K250501 · This AG · Ophthalmic

Nov 2025

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K250501 is an FDA 510(k) clearance for the System Sophi, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by This AG (Heerbrugg, CH). The FDA issued a Cleared decision on November 14, 2025, 267 days after receiving the submission on February 20, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number	K250501 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 20, 2025
Decision Date	November 14, 2025
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF