ARGON/KRYPTON LASER SYSTEM 8500— 510(k) K844209

Substantially Equivalent

Cooper Lasersonics, Inc.

FDA 510(k) clearance K844209 for ARGON/KRYPTON LASER SYSTEM 8500, Substantially Equivalent on 1985-02-06. Applicant: Cooper Lasersonics, Inc..

Clearance details

Applicant: Cooper Lasersonics, Inc.
Product code: Code HQB
Advisory panel: Ophthalmic
Date received: 1984-10-31
Decision date: 1985-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, 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.