ROPHAE DIAMOND KNIFE— 510(k) K861491

Substantially Equivalent

Rophae Lens Co., Inc.

FDA 510(k) clearance K861491 for ROPHAE DIAMOND KNIFE, Substantially Equivalent on 1986-05-28. Applicant: Rophae Lens Co., Inc..

Clearance details

Applicant: Rophae Lens Co., Inc.
Product code: Code HNN
Advisory panel: Ophthalmic
Date received: 1986-04-22
Decision date: 1986-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Petersburg, FL, US

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Adverse events under product code HNN

product code HNN

Injury: 183
Malfunction: 4,106
Total: 4,289

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.