TOPCON EC-200 ENDO-PHOTOCOAGULATOR LASER— 510(k) K903421

Substantially Equivalent

Top Con

FDA 510(k) clearance K903421 for TOPCON EC-200 ENDO-PHOTOCOAGULATOR LASER, Substantially Equivalent on 1990-12-18. Applicant: Top Con.

Clearance details

Applicant: Top Con
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 1990-07-31
Decision date: 1990-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paramus, NJ, US

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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.