AMER. MED. OPTICS ARGON/KRYPTON LASER— 510(k) K841856

Substantially Equivalent

American Medical Optics

FDA 510(k) clearance K841856 for AMER. MED. OPTICS ARGON/KRYPTON LASER, Substantially Equivalent on 1984-06-07. Applicant: American Medical Optics.

Clearance details

Applicant: American Medical Optics
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 1984-05-03
Decision date: 1984-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.