SKIN CLEAR SRVH LONG-PULSED 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 Skin Clear Srvh Long-pulsed Nd: Yag Laser.

Pre-market Notification Details

Device IDK080697
510k NumberK080697
Device Name:SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER
ClassificationPowered Laser Surgical Instrument
Applicant GLOBAL USA DISTRIBUTION, LLC. 9220 JAMES AVENUE SOUTH Minneapolis,  MN  55431
ContactRonald Berglund
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 Received2008-03-12
Decision Date2008-04-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800022300209 K080697 000

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