CERALAS DIODE LASER SYSTEM (CERALAS D2)— 510(k) K964751

Substantially Equivalent

Ceram Optec, Inc.

FDA 510(k) clearance K964751 for CERALAS DIODE LASER SYSTEM (CERALAS D2), Substantially Equivalent on 1997-02-21. Applicant: Ceram Optec, Inc..

Clearance details

Applicant: Ceram Optec, Inc.
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 1996-11-26
Decision date: 1997-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.