PALOMAR LUXIR FRACTIONAL HANDPIECE

Powered Laser Surgical Instrument

PALOMAR MEDICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Palomar Medical Technologies, Inc. with the FDA for Palomar Luxir Fractional Handpiece.

Pre-market Notification Details

Device IDK060069
510k NumberK060069
Device Name:PALOMAR LUXIR FRACTIONAL HANDPIECE
ClassificationPowered Laser Surgical Instrument
Applicant PALOMAR MEDICAL TECHNOLOGIES, INC. 131 KELEKENT LN. Cary,  NC  27511
ContactMarcy Moore
CorrespondentMarcy Moore
PALOMAR MEDICAL TECHNOLOGIES, INC. 131 KELEKENT LN. Cary,  NC  27511
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-01-09
Decision Date2006-03-02
Summary:summary

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