Cleared Abbreviated

K051186 - MICROPULSE PHACOEMULSIFICATION SYSTEM

K051186 is an FDA 510(k) clearance for MICROPULSE PHACOEMULSIFICATION SYSTEM, manufactured by Trillium Medical, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Abbreviated 510(k) pathway after a 101-day FDA review.

K051186 · Trillium Medical, Inc. · Ophthalmic device
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Aug 2005
Decision
101d
Days
Class 2
Risk

K051186 is an FDA 510(k) clearance for the MICROPULSE PHACOEMULSIFICATION SYSTEM. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Trillium Medical, Inc. (Poulsbo, US). The FDA issued a Cleared decision on August 18, 2005 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - the FDA ophthalmic device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Trillium Medical, Inc. devices

FDA 510(k) Submission Details - K051186

510(k) Number K051186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2005
Decision Date August 18, 2005
Days to Decision 101 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 110d · This submission: 101d
Pathway characteristics
Standards-based clearance path.

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 Peers - HQC Unit, Phacofragmentation

All 179
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