SKINCLEAR Q-SWITCHED ND:YAG LASER

Powered Laser Surgical Instrument

GLOBAL USA DISTRIBUTION, LLC.

The following data is part of a premarket notification filed by Global Usa Distribution, Llc. with the FDA for Skinclear Q-switched Nd:yag Laser.

Pre-market Notification Details

Device IDK083272
510k NumberK083272
Device Name:SKINCLEAR Q-SWITCHED ND:YAG LASER
ClassificationPowered Laser Surgical Instrument
Applicant GLOBAL USA DISTRIBUTION, LLC. 10723 AQUILA AV. S. Minneapolis,  MN  55438
ContactMatt Makousky
CorrespondentNed Devine
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-11-06
Decision Date2008-12-16
Summary:summary

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