Cleared Traditional

MODIFIED SITE TXR SYSTEMS (K925828) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K925828 · Site Microsurgical Systems, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
457d
Days
Class 2
Risk

K925828 is an FDA 510(k) clearance for the MODIFIED SITE TXR SYSTEMS. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Site Microsurgical Systems, Inc. (Horsham, US). The FDA issued a Cleared decision on February 16, 1994 after a review of 457 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Site Microsurgical Systems, Inc. devices

Submission Details

510(k) Number K925828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1992
Decision Date February 16, 1994
Days to Decision 457 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
347d slower than avg
Panel avg: 110d · This submission: 457d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - HQC Unit, Phacofragmentation

All 315
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K925828.
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
System Sophi
K250501 · This AG · Nov 2025
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