AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS— 510(k) K131893

Substantially Equivalent

Ajw Technology Consultants, Inc.

FDA 510(k) clearance K131893 for AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS, Substantially Equivalent on 2013-10-30. Applicant: Ajw Technology Consultants, Inc..

Clearance details

Applicant: Ajw Technology Consultants, Inc.
Product code: Code FSY
Advisory panel: General, Plastic Surgery
Date received: 2013-06-25
Decision date: 2013-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Apollo Beach, FL, US

Download summary PDF View on FDA.gov ↗

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.