ARGON LASER PHOTOCOAGULATOR SYS— 510(k) K843965

Substantially Equivalent

American Medical Optics

FDA 510(k) clearance K843965 for ARGON LASER PHOTOCOAGULATOR SYS, Substantially Equivalent on 1984-11-06. Applicant: American Medical Optics.

Clearance details

Applicant: American Medical Optics
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 1984-10-11
Decision date: 1984-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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.