LUXTEC ACO SERIES 4000 LIGHT SOURCE— 510(k) K890716

Name: FDA 510(k) clearance K890716
Creator: U.S. Food and Drug Administration
Published: 1989-04-26

Substantially Equivalent

Luxtec Corp.

FDA 510(k) clearance K890716 for LUXTEC ACO SERIES 4000 LIGHT SOURCE, Substantially Equivalent on 1989-04-26. Applicant: Luxtec Corp.. Device class: 2.

Clearance details

Applicant: Luxtec Corp.
Product code: Code FCW
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1989-02-13
Decision date: 1989-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sturbridge, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FCW

view all

K131226 — NOVAPROBE LED LIGHT SOURCE2014-07-24
K123956 — POWER LED 1752013-01-25
K123359 — OVS1 VIDEO SYSTEM2012-12-19
K121724 — ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.22012-09-20
K093792 — LED LIGHT SOURCE2010-03-18

More clearances from Luxtec Corp.

view all

K973193 — LUXSCOPE1997-11-21
K970642 — TENOSCOPE1997-05-21
K970562 — TENOSNARE1997-05-14
K950960 — REDDY ILLUMINATOR1995-09-08
K895248 — IMS5000 ILLUMINATED LOUPES1989-09-15

Adverse events under product code FCW

product code FCW

Malfunction: 912
Other: 1
Total: 913

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.