Cleared Traditional

K100702 - 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

K100702 is an FDA 510(k) clearance for STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, manufactured by Huot Instruments, LLC. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K100702 · Huot Instruments, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
130d
Days
Class 2
Risk

K100702 is an FDA 510(k) clearance for the STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE).... Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Huot Instruments, LLC (Menomonee Falls, US). The FDA issued a Cleared decision on July 20, 2010 after a review of 130 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Huot Instruments, LLC devices

FDA 510(k) Submission Details - K100702

510(k) Number K100702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2010
Decision Date July 20, 2010
Days to Decision 130 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 115d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FSY Device Classification - Class 2, Special Controls

Product Code FSY Light, Surgical, Ceiling Mounted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FSY Light, Surgical, Ceiling Mounted

All 29
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K100702.
CHROMOPHARE E 778 AND E 558
K083066 · Berchtold Holding GmbH · Oct 2008
CHROMOPHARE E-SERIES
K080857 · Berchtold Holding GmbH · Apr 2008
HARMONY LED-1 SURGICAL LIGHTING SYSTEM
K072072 · STERIS Corporation · Oct 2007
AURORA LED SERIES SURGICAL LIGHTS
K071698 · Skytron, Div. the Kmw Group, Inc. · Jul 2007
STRYKER VISUM SURGICAL LIGHTING SYSTEM
K031068 · Stryker Endoscopy · Aug 2003
CHROMOPHARE X 65
K024132 · Berchtold Holding GmbH · Mar 2003