MODEL 900K PHOTOCOAGULATOR— 510(k) K801336

Substantially Equivalent

Coherent Medical Division

FDA 510(k) clearance K801336 for MODEL 900K PHOTOCOAGULATOR, Substantially Equivalent on 1980-07-28. Applicant: Coherent Medical Division.

Clearance details

Applicant: Coherent Medical Division
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 1980-06-04
Decision date: 1980-07-28
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.