Cleared Traditional

K250501 - System Sophi

K250501 is an FDA 510(k) clearance for System Sophi, manufactured by This AG. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K250501 · This AG · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
267d
Days
Class 2
Risk

K250501 is an FDA 510(k) clearance for the System Sophi. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by This AG (Heerbrugg, CH). The FDA issued a Cleared decision on November 14, 2025 after a review of 267 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all This AG devices

FDA 510(k) Submission Details - K250501

510(k) Number K250501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 110d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQC Device Classification - Class 2, Special Controls

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Consultant

Regulatory Pathways Group, Inc.
Anne-Marie Ripley

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HQC Unit, Phacofragmentation

All 121
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K250501.
Stellaris Elite™ vision enhancement system
K261264 · Bausch and Lomb · May 2026
Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)
K252052 · Bausch and Lomb, Incorporated · Mar 2026
MICOR 700 with Auto I/A
K243395 · Carl Zeiss Meditec Cataract Technology, Inc. · Aug 2025
MICOR 700 System (N/A)
K242801 · Carl Zeiss Meditec Cataract Technology, Inc. · Jun 2025
Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
K240169 · Bausch and Lomb, Incorporated · Jul 2024
Faros Surgical System
K233398 · Oertli Instrumente AG · Jun 2024