ORION 3001, LASER PHOTOCOAGULATOR— 510(k) K864063

Substantially Equivalent

G. Rodenstock Instrumente GmbH

FDA 510(k) clearance K864063 for ORION 3001, LASER PHOTOCOAGULATOR, Substantially Equivalent on 1986-11-13. Applicant: G. Rodenstock Instrumente GmbH.

Clearance details

Applicant: G. Rodenstock Instrumente GmbH
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 1986-10-20
Decision date: 1986-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Munchen 70, West Germany, DE

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Adverse events under product code HQF

product code HQF

Injury: 166
Other: 1
Total: 167

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.