BURANE

Powered Laser Surgical Instrument

WAVELIGHT LASER TECHNOLOGIE AG

The following data is part of a premarket notification filed by Wavelight Laser Technologie Ag with the FDA for Burane.

Pre-market Notification Details

Device IDK052806
510k NumberK052806
Device Name:BURANE
ClassificationPowered Laser Surgical Instrument
Applicant WAVELIGHT LASER TECHNOLOGIE AG AM WOLFSMANTEL 5 Erlangen,  DE 91058
ContactAlexander Popp
CorrespondentJeffrey D Rongero
UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle,  NC  27709
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2005-10-04
Decision Date2005-10-17
Summary:summary

Trademark Results [BURANE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BURANE
BURANE
79007776 3181081 Dead/Cancelled
Alma Lasers Ltd.
2004-10-05

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