ISOLED AC-POWERED LED HEADLIGHT SYSTEM

Light, Surgical, Fiberoptic

ISOLUX LLC

The following data is part of a premarket notification filed by Isolux Llc with the FDA for Isoled Ac-powered Led Headlight System.

Pre-market Notification Details

Device IDK102266
510k NumberK102266
Device Name:ISOLED AC-POWERED LED HEADLIGHT SYSTEM
ClassificationLight, Surgical, Fiberoptic
Applicant ISOLUX LLC 1045 COLLIER CENTER WAY SUITE #6 Naples,  FL  34110 -8444
ContactNikolaus Andreoulakis
Product CodeFST  
CFR Regulation Number878.4580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2010-08-10
Decision Date2010-09-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
01816835024000 K102266 000
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