OPHTHALMIC SURGICAL INSTRUMENTS— 510(k) K864183

Substantially Equivalent

Techno Ophthalmics Intl.

FDA 510(k) clearance K864183 for OPHTHALMIC SURGICAL INSTRUMENTS, Substantially Equivalent on 1986-11-28. Applicant: Techno Ophthalmics Intl..

Clearance details

Applicant: Techno Ophthalmics Intl.
Product code: Code HNR
Advisory panel: Ophthalmic
Date received: 1986-10-27
Decision date: 1986-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HNR

product code HNR

Malfunction: 497
Other: 1
Total: 498

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.