DAYSTAR SURG. LIGHT 9100 & ORBITER 9110— 510(k) K771865

Substantially Equivalent

Castle Co.

FDA 510(k) clearance K771865 for DAYSTAR SURG. LIGHT 9100 & ORBITER 9110, Substantially Equivalent on 1977-11-28. Applicant: Castle Co..

Clearance details

Applicant: Castle Co.
Product code: Code FSY
Advisory panel: General, Plastic Surgery
Date received: 1977-10-03
Decision date: 1977-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FSY

product code FSY

Malfunction: 2,759
Other: 1
Total: 2,760

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.