FDA.reportPublic FDA data

ISOLUX LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10645153002249830ISOLUX LLC1N2020-04-251045 COLLIER CENTER WAY SUITE No. 6 NAPLES FL US 34110

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
008523500070061300XSB - 300 Watt Xenon Illuminator Used For Surgical Instrument Illumination.239-514-7475nick@isoluxllc.com
00852350007013Isolux llc - Bifurcated Fiber Optic Headlight Cable, Wolf, Lensed, 3.8mm x 8.5ft, Long ACMI239-514-7475nick@isoluxllc.com
00852350007020OptiLux LED Illuminator - LED Illuminator Used For Surgical Instrument Illumination239-514-7475nick@isoluxllc.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
226411389495161K991572ISOLUX SURGICAL HEADLIGHTFST1999-07-08
226411653082495K163185OptiLux LED IlluminatorHBI2016-11-21
226411046311739K102266ISOLED AC-POWERED LED HEADLIGHT SYSTEMFST2010-09-24
226411097072295K0529791125 XSB XENON FIBER-OPTIC LIGHT SOURCEHBI2005-10-31
226411275325035K022384XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBPHET2002-10-18
226411165060160
226411165299376
226411165643457
226411179738171
226411350327937
226411495345372
226411890397821

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HBI22016-11-21
FST22010-09-24
HET12002-10-18

PMN#

GUDID#