STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS— 510(k) K100702

Name: FDA 510(k) clearance K100702
Creator: U.S. Food and Drug Administration
Published: 2010-07-20

Substantially Equivalent

Huot Instruments, LLC

FDA 510(k) clearance K100702 for STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS, Substantially Equivalent on 2010-07-20. Applicant: Huot Instruments, LLC. Device class: 2.

Clearance details

Applicant: Huot Instruments, LLC
Product code: Code FSY
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2010-03-12
Decision date: 2010-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menomonee Falls, WI, US

Download summary PDF View on FDA.gov ↗

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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.