LUTEX HEADLIGHT SYSTEMS

Light, Surgical, Fiberoptic

LUXTEC CORP.

The following data is part of a premarket notification filed by Luxtec Corp. with the FDA for Lutex Headlight Systems.

Pre-market Notification Details

Device IDK864380
510k NumberK864380
Device Name:LUTEX HEADLIGHT SYSTEMS
ClassificationLight, Surgical, Fiberoptic
Applicant LUXTEC CORP. P.O. BOX 225, RTE 20/49 TECHNO PARK RD Sturbridge,  MA  01566
ContactThomas Wilk
CorrespondentThomas Wilk
LUXTEC CORP. P.O. BOX 225, RTE 20/49 TECHNO PARK RD Sturbridge,  MA  01566
Product CodeFST  
CFR Regulation Number878.4580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-11-05
Decision Date1986-11-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M40500290091 K864380 000
M433001387LX1 K864380 000
M433001380LX1 K864380 000
M433001370LX1 K864380 000
M4330013371 K864380 000
M4330013281 K864380 000
M433001290BIFREP1 K864380 000
M433001290BIF01 K864380 000
M433001270BIF1 K864380 000
M433001234LX1 K864380 000
M433001170BIF1 K864380 000
M4330002861 K864380 000
M433495361 K864380 000
M4334003551 K864380 000
M433400282LX1 K864380 000
M433004810LX1 K864380 000
M405001388LX111 K864380 000
M405001388LX91 K864380 000
M405002900111 K864380 000
M4050023009S1 K864380 000
M4050023009G1 K864380 000
M40500230091 K864380 000
M405002242A1 K864380 000
H834D052750011 K864380 000
M433AX2100BIF1 K864380 000
M433AX1385BIF1 K864380 000
M433AX1375BIF1 K864380 000
M43390013PX1 K864380 000
M43390012PX1 K864380 000
M433005331LX1 K864380 000
M43304715LX1 K864380 000
M433002008LX1 K864380 000
M433001775LX1 K864380 000
M4330011901 K864380 000

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