TRI-STAR UNIVERSAL I/A PHACO PAK— 510(k) K953359

Name: FDA 510(k) clearance K953359
Creator: U.S. Food and Drug Administration
Published: 1995-10-17

Substantially Equivalent

Tri-Star Ophthalmic

FDA 510(k) clearance K953359 for TRI-STAR UNIVERSAL I/A PHACO PAK, Substantially Equivalent on 1995-10-17. Applicant: Tri-Star Ophthalmic. Device class: 2.

Clearance details

Applicant: Tri-Star Ophthalmic
Product code: Product code HQC
Device class: Class 2
Regulation: 21 CFR 886.4670
Advisory panel: Ophthalmic
Date received: 1995-07-17
Decision date: 1995-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longwood, FL, US

Download summary PDF View on FDA.gov ↗

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K250501 — System Sophi2025-11-14
K243395 — MICOR 700 with Auto I/A2025-08-08

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K914229 — PHACO TIP1991-12-27

Adverse events under product code HQC

product code HQC

Injury: 2,378
Malfunction: 8,768
Total: 11,146

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.