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510(k) K013511

Device
XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)
Applicant
ACULUX, INC.
510(k) number
K013511
Product code
FSW  
Decision
Substantially Equivalent (SESE)
Decision date
2002-02-01
Date received
2001-10-22
Regulation
878.4580
Classification name
Light, Surgical, Endoscopic
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KIM MARSH
Address
273 S. Airport Pulling Rd. Naples FL US 34104 34104

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FSW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K022989RADLITE TISSUE RETRACTOR SYSTEMGenzyme Biosurgery2002-11-25
K943342MEDICAM XENON LIGHT SOURCEM.P. Video, Inc.1994-10-17
K934337CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCECuda Products Co.1993-11-18
K922279ILLUMINATOR IV MINOR SURGERY LIGHTMedical Illumination, Inc.1992-09-02
K913135LM-300TWINLeisegang Medical, Inc.1991-09-18
K894319MEDICAL DYNAMICS LIGHT SOURCEMedical Dynamics, Inc.1989-10-03
K870898ULTRA-LUX LIGHT SOURCEMedline Industries, Inc.1987-03-18

Legacy Summary#

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FDA Review#

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