Cleared Traditional

K111342 - LIGHT GUIDE CABLE

K111342 is an FDA 510(k) clearance for LIGHT GUIDE CABLE, manufactured by Schott North America. The device is a Class 2 General & Plastic Surgery device with product code HBI cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K111342 · Schott North America · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
196d
Days
Class 2
Risk

K111342 is an FDA 510(k) clearance for the LIGHT GUIDE CABLE. Classified as Illuminator, Fiberoptic, Surgical Field (product code HBI), Class II - Special Controls.

Submitted by Schott North America (North Attleboro, US). The FDA issued a Cleared decision on November 25, 2011 after a review of 196 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K111342

510(k) Number K111342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2011
Decision Date November 25, 2011
Days to Decision 196 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 115d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBI Device Classification - Class 2, Special Controls

Product Code HBI Illuminator, Fiberoptic, Surgical Field
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 - HBI Illuminator, Fiberoptic, Surgical Field

All 26
Devices cleared under the same product code (HBI) and FDA review panel - the closest regulatory comparables to K111342.
Light-Guide Cables
K223183 · Olympus Winter & Ibe GmbH · Jan 2023
OptiLux LED Illuminator
K163185 · Isolux, LLC · Nov 2016
KOGENT SPETZLER LIGHTED SUCTION TUBES
K141781 · Katalyst Surgical, LLC · Apr 2015
1125 XSB XENON FIBER-OPTIC LIGHT SOURCE
K052979 · Isolux, LLC · Oct 2005
ENDOSCOPIC FIBEROPTIC CABLE
K021931 · Gulf Medical Fiberoptics · Sep 2002
ENDOSCOPIC FIBEROPTIC CABLE
K991208 · Isolux America · Jun 1999
K111342 · LIGHT GUIDE CABLE
Download PDF FDA Summary Schott North America