CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT

Powered Laser Surgical Instrument

BIOLITEC, INC.

The following data is part of a premarket notification filed by Biolitec, Inc. with the FDA for Ceralas D 10-60 810nm Laser System With Endo Laser Vein System Kit.

Pre-market Notification Details

Device IDK030700
510k NumberK030700
Device Name:CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT
ClassificationPowered Laser Surgical Instrument
Applicant BIOLITEC, INC. 555 THIRTEENTH ST., NW Washington,  DC  20004 -1109
ContactJonathan S Kahan
CorrespondentJonathan S Kahan
BIOLITEC, INC. 555 THIRTEENTH ST., NW Washington,  DC  20004 -1109
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-06
Decision Date2003-06-04
Summary:summary

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