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510(k) K250501

System Sophi by This AG — Product Code HQC

K250501 is an FDA 510(k) premarket notification submitted by This AG for the device "System Sophi". The FDA issued a decision of Substantially Equivalent on November 14, 2025. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2025
Date Received
February 20, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type

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FDA data resources