510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100702Substantially Equivalent

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

Huot Instruments, LLC, Menomonee Falls WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100702 is the FDA 510(k) clearance record 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, a class II device, cleared for Huot Instruments, LLC on under FDA product code FSY (Light, Surgical, Ceiling Mounted). FDA records list one 510(k) clearance for Huot Instruments, LLC. As of , FDA records show no recalls naming K100702.

Clearance record

Decision date
Received
(130 days to decision)
Product code
FSY Light, Surgical, Ceiling Mounted
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Huot Instruments, LLC N50 W13740 Overview Dr., Menomonee Falls WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FSY

Trailing 12 months

FDA records hold no clearances under product code FSY in the trailing twelve months.

FDA records show no clearances under product code FSY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FSY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260