Cleared Traditional

K013511 - XENALIGHT MODELS # AX9125 (100-120V~)

Also marketed or referenced as:
# AX9225 (220-240V~)

K013511 is an FDA 510(k) clearance for XENALIGHT MODELS # AX9125 (100-120V~), manufactured by Aculux, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FSW cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K013511 · Aculux, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
102d
Days
Class 2
Risk

K013511 is an FDA 510(k) clearance for the XENALIGHT MODELS # AX9125 (100-120V~). Classified as Light, Surgical, Endoscopic (product code FSW), Class II - Special Controls.

Submitted by Aculux, Inc. (Naples, US). The FDA issued a Cleared decision on February 1, 2002 after a review of 102 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.

FDA 510(k) Submission Details - K013511

510(k) Number K013511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2001
Decision Date February 01, 2002
Days to Decision 102 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 115d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FSW Device Classification - Class 2, Special Controls

Product Code FSW Light, Surgical, Endoscopic
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 - FSW Light, Surgical, Endoscopic

All 7
Devices cleared under the same product code (FSW) and FDA review panel - the closest regulatory comparables to K013511.
RADLITE TISSUE RETRACTOR SYSTEM
K022989 · Genzyme Biosurgery · Nov 2002
MEDICAM XENON LIGHT SOURCE
K943342 · M.P. Video, Inc. · Oct 1994
CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE
K934337 · Cuda Products Co. · Nov 1993
ILLUMINATOR IV MINOR SURGERY LIGHT
K922279 · Medical Illumination, Inc. · Sep 1992
LM-300TWIN
K913135 · Leisegang Medical, Inc. · Sep 1991
MEDICAL DYNAMICS LIGHT SOURCE
K894319 · Medical Dynamics, Inc. · Oct 1989
K013511 · XENALIGHT MODELS # AX9125 (100-120V~)
Download PDF Aculux, Inc.