OPTHALMIC SURGICAL INSTRUMENTS— 510(k) K860744

Name: FDA 510(k) clearance K860744
Creator: U.S. Food and Drug Administration
Published: 1986-03-31

Substantially Equivalent

Tridak Division of Indicon, Inc.

FDA 510(k) clearance K860744 for OPTHALMIC SURGICAL INSTRUMENTS, Substantially Equivalent on 1986-03-31. Applicant: Tridak Division of Indicon, Inc.. Device class: 1.

Clearance details

Applicant: Tridak Division of Indicon, Inc.
Product code: Code HMX
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1986-02-27
Decision date: 1986-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pearl River, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HMX

product code HMX

Other: 1
Total: 1

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.