510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K051186Substantially Equivalent

Micropulse Phacoemulsification System

Trillium Medical, Inc., Poulsbo WA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051186 is the FDA 510(k) clearance record for MICROPULSE PHACOEMULSIFICATION SYSTEM, a class II device, cleared for Trillium Medical, Inc. on under FDA product code HQC (Unit, Phacofragmentation). FDA records list one 510(k) clearance for Trillium Medical, Inc. As of , FDA records show no recalls naming K051186.

Clearance record

Decision date
Received
(101 days to decision)
Product code
HQC Unit, Phacofragmentation
Regulation
21 CFR 886.4670
Device class
Class II
Review panel
Ophthalmic
Applicant
Trillium Medical, Inc. P.O. Box 2601, Poulsbo WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HQC

Trailing 12 months
3 clearances under product code HQC in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HQC, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260