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

Name: FDA 510(k) clearance K131893
Creator: U.S. Food and Drug Administration
Published: 2013-10-30

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.. Device class: 2.

Clearance details

Applicant: Ajw Technology Consultants, Inc.
Product code: Code FSY
Device class: Class 2
Regulation: 21 CFR 878.4580
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 ↗

Recent devices under product code FSY

view all

K142984 — Leo Minor2014-10-29
K142076 — CLAVEGUARD FREEDOM SURGICAL LIGHT2014-09-30
K140812 — MI-750 PROCEDURAL/MINOR SURGICAL LIGHT2014-08-07
K132551 — ZF 7202014-06-30
K140930 — VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES2014-06-09

More clearances from Ajw Technology Consultants, Inc.

view all

K141104 — TRUKLEAR BRACKET2014-06-25

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.