ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS— 510(k) K844197

Substantially Equivalent

Nidek, Inc.

FDA 510(k) clearance K844197 for ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS, Substantially Equivalent on 1984-12-24. Applicant: Nidek, Inc..

Clearance details

Applicant: Nidek, Inc.
Product code: Code HQB
Advisory panel: Ophthalmic
Date received: 1984-10-30
Decision date: 1984-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

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Adverse events under product code HQB

product code HQB

Other: 2
Total: 2

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.